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CompletedNCT00511433Updated Feb 9, 2022Results posted

Effects on Ovarian Function of the Combined Oral Contraceptive NOMAC-E2 Compared to a COC Containing DRSP/EE (292003)(COMPLETED)(P05723)

A Phase 3 interventional study of NOMAC-E2 and DRSP-EE in Contraception, sponsored by Organon and Co. Completed. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-09.

Sponsored by Organon and Co · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
Female
01

Study summary

The primary purpose of this study is to evaluate the effects of the nomegestrol acetate-estradiol (NOMAC-E2) combined oral contraceptive (COC) on ovarian function.

02

Conditions studied

  • Contraception
03

In context

Lead sponsor

Organon and Co is the lead sponsor of 505 studies on the registry; none are open to participants now.

Of its 22 completed or terminated interventional studies of FDA-regulated products, 18 (82%) have results posted.

Browse Organon & Co. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Willing to use COC for at least 6 cycles.
  • 18 - 35 years of age at screening.
  • Body Mass Index (BMI) of >/= 17 and \</= 35.
  • Good physical and mental health.
  • Willing to use condoms as the sole contraceptive method during screening cycle and 1 post-treatment cycle.
  • Willing to give informed consent.

Exclusion criteria

Exclusion Criteria:

  • Contraindications for contraceptive steroids (general).
  • Additional contraindications (renal, hepatic or adrenal insufficiency).
  • Breastfeeding.
  • Present use (or use within 2 months prior to start of the trial medication) of the following drugs: phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate, rifampicin, nelfinavir, ritonavir, griseofulvin, ketoconazole, sex

steroids (other than pre- and post treatment contraceptive method) and herbal remedies containing Hypericum perforatum (St. John's Wort).

  • Administration of any other investigational drugs and/or participation in another clinical trial within 2 months prior to the start of the trial medication or during the trial period.
  • Abnormal cervical smear at screening, or documentation of an abnormal smear performed within 6 months before screening.
  • Clinically relevant abnormal laboratory result at screening as judged by the investigator.
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    NOMAC-E2

    Nomegestrol Acetate (NOMAC) and Estradiol (E2), 2.5 mg NOMAC and 1.5 mg E2 monophasic combined oral contraceptive

    Drug: NOMAC-E2

  • Active comparator
    DRSP-EE

    Drospirenone (DRSP) and Ethinyl Estradiol (EE), 3 mg DRSP and 30 mcg EE monophasic combined oral contraceptive

    Drug: DRSP-EE

Interventions

  • DrugNOMAC-E2

    Drug pages: Nomegestrol acetate · Estradiol

    Nomegestrol Acetate and Estradiol Tablets, 2.5 mg NOMAC and 1.5 mg E2 taken once daily from Day 1 of menstrual period up to and including Day 28 for 6 consecutive 28-day menstrual cycles.

  • DrugDRSP-EE

    Drospirenone and Ethinyl Estradiol Tablets, 3 mg DRSP and 30 mcg EE taken once daily from Day 1 of menstrual period up to and including Day 28 for 6 consecutive 28-day menstrual cycles.

06

What researchers measure

Primary outcomes

  1. Effect on Ovarian Function as Determined by the Number of Participants With an Occurrence of Ovulation

    During treatment, ovulation was assessed for each participant by the investigator on the basis of ultrasound scanning (USS). The final analysis was based on assessor-blind adjudication.

    Time frame: Cycle 1, Cycle 2, and Cycle 6

  2. Effect on Ovarian Function as Determined by the Maximum Follicle Diameter

    The maximum follicular diameter was defined as the largest follicular diameter during a treatment cycle.

    Time frame: Screening cycle, Cycle 1, Cycle 2, Cycle 3, and Cycle 6

  3. Effect on Ovarian Function as Determined by the Maximum Progesterone Value

    The maximum progesterone value was defined as the largest value during a cycle.

    Time frame: Screening cycle, Cycle 1, Cycle 2, Cycle 3, and Cycle 6

  4. Effect on Ovarian Function as Determined by 17 Beta-estradiol (E2)

    The parameter was measured at pre-defined study days.

    Time frame: Cycle 1, Cycle 2, Cycle 3, and Cycle 6

  5. Effect on Ovarian Function as Determined by Follicle Stimulating Hormone (FSH)

    The parameter was measured at pre-defined study days.

    Time frame: Cycle 1, Cycle 2, Cycle 3, and Cycle 6

  6. Effect on Ovarian Function as Determined by Luteinizing Hormone (LH)

    The parameter was measured at pre-defined study days.

    Time frame: Cycle 1, Cycle 2, Cycle 3, and Cycle 6

Secondary outcomes

  1. Effect on Cervical Mucus as Determined by Insler Score

    The Insler Score was assessed on Day 6 after ovulation during the Screening Cycle, on Day 21 of Cycle 1, and when the maximum follicle diameter was greater than or equal to 15 mm. The Insler Score consisted of four categories each scaled from 0 (none) to 3 (complete). The higher the score, the greater the cervical reaction.

    Time frame: Screening Cycle, Cycle 1, Cycle 2, and Cycle 7 (post-treatment cycle)

  2. Effect on Maximum Endometrial Thickness

    Maximum endometrial thickness was defined as the largest endometrial thickness during a cycle.

    Time frame: Screening Cycle, Cycle 1, Cycle 2, and Cycle 6

  3. Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index)

    In-treatment pregnancies were pregnancies with an estimated date of conception from the day of first intake of trial medication up to and including the day of last (active or placebo) intake of trial medication extended with a maximum of two days. Each 13 cycles (28 days per cycle) of exposure constitutes a woman year. The Pearl Index was obtained by dividing the number of in-treatment pregnancies that occurred by the time (in 100 woman years) that the women were under risk of becoming pregnant.

    Time frame: 6 cycles

  4. Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting

    Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding/spotting was defined as any episode that occurred during the "expected non-bleeding period" that was neither an early nor a continued withdrawal bleeding. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle.

    Time frame: Every 28-day cycle for 6 cycles

  5. Number of Participants With an Occurrence of Absence of Withdrawal Bleeding

    Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Absence of withdrawal bleeding was defined as no bleeding/spotting episode that began during or continued into the "expected bleeding period". Expected bleeding period: DRSP-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle.

    Time frame: Every 28-day cycle for 6 cycles

  6. Number of Participants With an Occurrence of Breakthrough Bleeding

    Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding was defined as any bleeding episode that occurred during the "expected non-bleeding period" that was neither part of an early nor continued withdrawal bleeding. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2:21-day period starting on Day 4 of the cycle.

    Time frame: Every 28-day cycle for 6 cycles

  7. Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only)

    Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough spotting was defined as any spotting episode that occurred during the "expected non-bleeding period" that was neither part of an early nor continued withdrawal bleeding. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2:21-day period starting on Day 4 of the cycle.

    Time frame: Every 28-day cycle for 6 cycles

  8. Number of Participants With an Occurrence of Early Withdrawal Bleeding

    Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Early withdrawal bleeding was defined as any withdrawal bleeding that started before the current "expected bleeding period". Expected bleeding period: DRSP-EE: 7-day period starting on Day 22 of the cycle; NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle.

    Time frame: Every 28-day cycle for 6 cycles

  9. Number of Participants With an Occurrence of Continued Withdrawal Bleeding

    Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Continued withdrawal bleeding was defined as any withdrawal bleeding that continued into the "expected non-bleeding period" of the next cycle. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle.

    Time frame: Every 28-day cycle for 5 cycles

  10. Average Number of Breakthrough Bleeding/Spotting Days

    Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding/spotting was defined as any episode that occurred during the "expected non-bleeding period" that was neither an early nor a continued withdrawal bleeding. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle.

    Time frame: Every 28-day cycle for 6 cycles

  11. Average Number of Withdrawal Bleeding Days

    Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Withdrawal bleeding was defined as bleeding/spotting episode that started during or continued into the "expected bleeding period". Expected bleeding period: DRSP-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle.

    Time frame: Every 28-day cycle for 6 cycles

07

Results

Posted Aug 29, 2011

Participant flow

Participant flow — Overall Study
MilestoneNOMAC-E2DRSP-EE
Started3216
Completed2615
Not completed61
Withdrew: Adverse event50
Withdrew: Other reason11

Outcome measures

SecondaryEffect on Cervical Mucus as Determined by Insler Score

The Insler Score was assessed on Day 6 after ovulation during the Screening Cycle, on Day 21 of Cycle 1, and when the maximum follicle diameter was greater than or equal to 15 mm. The Insler Score consisted of four categories each scaled from 0 (none) to 3 (complete). The higher the score, the greater the cervical reaction.

Time frame:
Screening Cycle, Cycle 1, Cycle 2, and Cycle 7 (post-treatment cycle)
Reported as:
Mean · score on a scale
Effect on Cervical Mucus as Determined by Insler Score
score on a scaleNOMAC-E2DRSP-EE
Screening cycle (n=32 NOMAC-E2 / n=16 DRSP-EE)8.9 ± 2.557.3 ± 3.61
Cycle 1 (n=30 NOMAC-E2 / n=15 DRSP-EE)2.3 ± 1.933.2 ± 2.43
Cycle 2 (n=0 NOMAC-E2 / n=2 DRSP-EE)NA ± NA4.5 ± 0.71
Cycle 7 (n=22 NOMAC-E2 / n=15 DRSP-EE)7.0 ± 2.948.7 ± 1.53
SecondaryEffect on Maximum Endometrial Thickness

Maximum endometrial thickness was defined as the largest endometrial thickness during a cycle.

Time frame:
Screening Cycle, Cycle 1, Cycle 2, and Cycle 6
Reported as:
Mean · mm
Effect on Maximum Endometrial Thickness
mmNOMAC-E2DRSP-EE
Screening cycle (n=32 NOMAC-E2 / n=16 DRSP-EE)9.9 ± 1.9110.1 ± 2.50
Cycle 1 (n=32 NOMAC-E2 / n=16 DRSP-EE)5.9 ± 1.226.1 ± 1.25
Cycle 2 (n=29 NOMAC-E2 / n=16 DRSP-EE)5.3 ± 0.716.8 ± 1.73
Cycle 6 (n=26 NOMAC-E2 / n=15 DRSP-EE)4.9 ± 0.665.5 ± 1.30
SecondaryNumber of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index)

In-treatment pregnancies were pregnancies with an estimated date of conception from the day of first intake of trial medication up to and including the day of last (active or placebo) intake of trial medication extended with a maximum of two days. Each 13 cycles (28 days per cycle) of exposure constitutes a woman year. The Pearl Index was obtained by dividing the number of in-treatment pregnancies that occurred by the time (in 100 woman years) that the women were under risk of becoming pregnant.

Time frame:
6 cycles
Reported as:
Number · Pregnancies per 100 woman years
Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index)
Pregnancies per 100 woman yearsNOMAC-E2DRSP-EE
Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index)0 (0 to 45.9)0 (0 to 72.7)
SecondaryNumber of Participants With an Occurrence of Breakthrough Bleeding/Spotting

Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding/spotting was defined as any episode that occurred during the "expected non-bleeding period" that was neither an early nor a continued withdrawal bleeding. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle.

Time frame:
Every 28-day cycle for 6 cycles
Reported as:
Number · Participants
Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting
ParticipantsNOMAC-E2DRSP-EE
Cycle 1 (n=30 NOMAC-E2 / n=16 DRSP-EE)71
Cycle 2 (n=27 NOMAC-E2 / n=16 DRSP-EE)60
Cycle 3 (n=26 NOMAC-E2 / n=15 DRSP-EE)50
Cycle 4 (n=26 NOMAC-E2 / n=15 DRSP-EE)50
Cycle 5 (n=26 NOMAC-E2 / n=15 DRSP-EE)80
Cycle 6 (n=26 NOMAC-E2 / n=14 DRSP-EE)50
SecondaryNumber of Participants With an Occurrence of Absence of Withdrawal Bleeding

Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Absence of withdrawal bleeding was defined as no bleeding/spotting episode that began during or continued into the "expected bleeding period". Expected bleeding period: DRSP-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle.

Time frame:
Every 28-day cycle for 6 cycles
Reported as:
Number · Participants
Number of Participants With an Occurrence of Absence of Withdrawal Bleeding
ParticipantsNOMAC-E2DRSP-EE
Cycle 1 (n=30 NOMAC-E2 / n=16 DRSP-EE)30
Cycle 2 (n=27 NOMAC-E2 / n=16 DRSP-EE)20
Cycle 3 (n=26 NOMAC-E2 / n=15 DRSP-EE)20
Cycle 4 (n=26 NOMAC-E2 / n=15 DRSP-EE)20
Cycle 5 (n=26 NOMAC-E2 / n=15 DRSP-EE)20
Cycle 6 (n=26 NOMAC-E2 / n=14 DRSP-EE)41
SecondaryNumber of Participants With an Occurrence of Breakthrough Bleeding

Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding was defined as any bleeding episode that occurred during the "expected non-bleeding period" that was neither part of an early nor continued withdrawal bleeding. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2:21-day period starting on Day 4 of the cycle.

Time frame:
Every 28-day cycle for 6 cycles
Reported as:
Number · Participants
Number of Participants With an Occurrence of Breakthrough Bleeding
ParticipantsNOMAC-E2DRSP-EE
Cycle 1 (n=30 NOMAC-E2 / n=16 DRSP-EE)00
Cycle 2 (n=27 NOMAC-E2 / n=16 DRSP-EE)00
Cycle 3 (n=26 NOMAC-E2 / n=15 DRSP-EE)00
Cycle 4 (n=26 NOMAC-E2 / n=15 DRSP-EE)10
Cycle 5 (n=26 NOMAC-E2 / n=15 DRSP-EE)10
Cycle 6 (n=26 NOMAC-E2 / n=14 DRSP-EE)00
SecondaryNumber of Participants With an Occurrence of Breakthrough Spotting (Spotting Only)

Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough spotting was defined as any spotting episode that occurred during the "expected non-bleeding period" that was neither part of an early nor continued withdrawal bleeding. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2:21-day period starting on Day 4 of the cycle.

Time frame:
Every 28-day cycle for 6 cycles
Reported as:
Number · Participants
Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only)
ParticipantsNOMAC-E2DRSP-EE
Cycle 1 (n=30 NOMAC-E2 / n=16 DRSP-EE)71
Cycle 2 (n=27 NOMAC-E2 / n=16 DRSP-EE)60
Cycle 3 (n=26 NOMAC-E2 / n=15 DRSP-EE)50
Cycle 4 (n=26 NOMAC-E2 / n=15 DRSP-EE)40
Cycle 5 (n=26 NOMAC-E2 / n=15 DRSP-EE)70
Cycle 6 (n=26 NOMAC-E2 / n=14 DRSP-EE)50
SecondaryNumber of Participants With an Occurrence of Early Withdrawal Bleeding

Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Early withdrawal bleeding was defined as any withdrawal bleeding that started before the current "expected bleeding period". Expected bleeding period: DRSP-EE: 7-day period starting on Day 22 of the cycle; NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle.

Time frame:
Every 28-day cycle for 6 cycles
Reported as:
Number · Participants
Number of Participants With an Occurrence of Early Withdrawal Bleeding
ParticipantsNOMAC-E2DRSP-EE
Cycle 1 (n=30 NOMAC-E2 / n=16 DRSP-EE)42
Cycle 2 (n=27 NOMAC-E2 / n=16 DRSP-EE)40
Cycle 3 (n=26 NOMAC-E2 / n=15 DRSP-EE)10
Cycle 4 (n=26 NOMAC-E2 / n=15 DRSP-EE)20
Cycle 5 (n=26 NOMAC-E2 / n=15 DRSP-EE)10
Cycle 6 (n=26 NOMAC-E2 / n=14 DRSP-EE)20
SecondaryNumber of Participants With an Occurrence of Continued Withdrawal Bleeding

Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Continued withdrawal bleeding was defined as any withdrawal bleeding that continued into the "expected non-bleeding period" of the next cycle. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle.

Time frame:
Every 28-day cycle for 5 cycles
Reported as:
Number · Participants
Number of Participants With an Occurrence of Continued Withdrawal Bleeding
ParticipantsNOMAC-E2DRSP-EE
Cycle 1 (n=29 NOMAC-E2 / n=16 DRSP-EE)1112
Cycle 2 (n=27 NOMAC-E2 / n=16 DRSP-EE)810
Cycle 3 (n=25 NOMAC-E2 / n=15 DRSP-EE)811
Cycle 4 (n=26 NOMAC-E2 / n=15 DRSP-EE)1212
Cycle 5 (n=26 NOMAC-E2 / n=14 DRSP-EE)910
PrimaryEffect on Ovarian Function as Determined by the Number of Participants With an Occurrence of Ovulation

During treatment, ovulation was assessed for each participant by the investigator on the basis of ultrasound scanning (USS). The final analysis was based on assessor-blind adjudication.

Time frame:
Cycle 1, Cycle 2, and Cycle 6
Reported as:
Number · Participants
Effect on Ovarian Function as Determined by the Number of Participants With an Occurrence of Ovulation
ParticipantsNOMAC-E2DRSP-EE
Cycle 1 (n=32 NOMAC-E2 / n=16 DRSP-EE)00
Cycle 2 (n=29 NOMAC-E2 / n=16 DRSP-EE)00
Cycle 6 (n=26 NOMAC-E2 / n=15 DRSP-EE)00
PrimaryEffect on Ovarian Function as Determined by the Maximum Follicle Diameter

The maximum follicular diameter was defined as the largest follicular diameter during a treatment cycle.

Time frame:
Screening cycle, Cycle 1, Cycle 2, Cycle 3, and Cycle 6
Reported as:
Mean · millimeters (mm)
Effect on Ovarian Function as Determined by the Maximum Follicle Diameter
millimeters (mm)NOMAC-E2DRSP-EE
Screening cycle (n=32 NOMAC-E2 / n=16 DRSP-EE)19.3 ± 3.1319.6 ± 4.32
Cycle 1 (n=32 NOMAC-E2 / n=16 DRSP-EE)7.6 ± 1.518.1 ± 1.98
Cycle 2 (n=29 NOMAC-E2 / n=16 DRSP-EE)8.2 ± 1.8210.8 ± 4.76
Cycle 3 (n=27 NOMAC-E2 / n=14 DRSP-EE)7.8 ± 1.888.4 ± 2.31
Cycle 6 (n=26 NOMAC-E2 / n=15 DRSP-EE)6.9 ± 2.077.4 ± 2.06
PrimaryEffect on Ovarian Function as Determined by the Maximum Progesterone Value

The maximum progesterone value was defined as the largest value during a cycle.

Time frame:
Screening cycle, Cycle 1, Cycle 2, Cycle 3, and Cycle 6
Reported as:
Mean · nanomoles per liter (nmol/L)
Effect on Ovarian Function as Determined by the Maximum Progesterone Value
nanomoles per liter (nmol/L)NOMAC-E2DRSP-EE
Screening cycle (n=32 NOMAC-E2 / n=16 DRSP-EE)38.7 ± 12.6238.7 ± 17.01
Cycle 1 (n=32 NOMAC-E2 / n=16 DRSP-EE)1.7 ± 0.461.6 ± 0.28
Cycle 2 (n=29 NOMAC-E2 / n=16 DRSP-EE)1.5 ± 0.461.5 ± 0.26
Cycle 3 (n=27 NOMAC-E2 / n=14 DRSP-EE)1.26 ± 0.101.34 ± 0.27
Cycle 6 (n=26 NOMAC-E2 / n=15 DRSP-EE)1.3 ± 0.291.5 ± 0.26
PrimaryEffect on Ovarian Function as Determined by 17 Beta-estradiol (E2)

The parameter was measured at pre-defined study days.

Time frame:
Cycle 1, Cycle 2, Cycle 3, and Cycle 6
Reported as:
Mean · picomoles per liter (pmol/L)
Effect on Ovarian Function as Determined by 17 Beta-estradiol (E2)
picomoles per liter (pmol/L)NOMAC-E2DRSP-EE
Cycle 1, Day 2 (n=32 NOMAC-E2 / n=16 DRSP-EE)168.75 ± 62.3779.82 ± 18.34
Cycle 1, Day 5 (n=32 NOMAC-E2 / n=16 DRSP-EE)194.57 ± 93.1766.66 ± 10.53
Cycle 1, Day 8 (n=32 NOMAC-E2 / n=16 DRSP-EE)172.35 ± 66.9261.15 ± 3.66
Cycle 1, Day 11 (n=30 NOMAC-E2 / n=16 DRSP-EE)184.63 ± 95.7060.51 ± 1.96
Cycle 1, Day 14 (n=29 NOMAC-E2 / n=16 DRSP-EE)197.57 ± 123.2360.26 ± 1.48
Cycle 1, Day 18 (n=29 NOMAC-E2 / n=16 DRSP-EE)182.72 ± 84.0360.58 ± 2.93
Cycle 1, Day 21 (n=30 NOMAC-E2 / n=16 DRSP-EE)191.08 ± 139.5059.82 ± 0
Cycle 1, Day 24 (n=30 NOMAC-E2 / n=16 DRSP-EE)232.80 ± 281.1569.84 ± 23.50
Cycle 1, Day 27 (n=30 NOMAC-E2 / n=16 DRSP-EE)99.65 ± 42.53150.79 ± 46.45
Cycle 2, Day 2 (n=29 NOMAC-E2 / n=16 DRSP-EE)176.43 ± 91.99135.86 ± 106.62
Cycle 2, Day 5 (n=29 NOMAC-E2 / n=15 DRSP-EE)213.64 ± 104.85142.74 ± 186.99
Cycle 2, Day 8 (n=29 NOMAC-E2 / n=16 DRSP-EE)192.59 ± 68.83131.98 ± 196.51
Cycle 2, Day 11 (n=29 NOMAC-E2 / n=16 DRSP-EE)185.77 ± 63.97112.23 ± 152.19
Cycle 2, Day 14 (n=29 NOMAC-E2 / n=15 DRSP-EE)183.66 ± 74.3978.44 ± 69.99
Cycle 2, Day 18 (n=28 NOMAC-E2 / n=15 DRSP-EE)213.84 ± 123.3560.11 ± 0.95
Cycle 2, Day 21 (n=27 NOMAC-E2 / n=16 DRSP-EE)192.47 ± 66.4359.91 ± 0.37
Cycle 2, Day 24 (n=27 NOMAC-E2 / n=16 DRSP-EE)206.20 ± 147.2761.33 ± 3.95
Cycle 2, Day 27 (n=27 NOMAC-E2 / n=16 DRSP-EE)97.99 ± 40.88155.63 ± 63.65
Cycle 3, Day 2 (n=27 NOMAC-E2 / n=14 DRSP-EE)148.16 ± 52.09141.11 ± 115.89
Cycle 6, Day 14 (n=25 NOMAC-E2 / n=14 DRSP-EE)205.89 ± 104.4559.98 ± 0.59
Cycle 6, Day 18 (n=26 NOMAC-E2 / n=15 DRSP-EE)200.04 ± 90.2864.20 ± 12.99
Cycle 6, Day 21 (n=26 NOMAC-E2 / n=15 DRSP-EE)188.47 ± 90.1260.82 ± 3.02
Cycle 6, Day 24 (n=26 NOMAC-E2 / n=14 DRSP-EE)187.16 ± 106.6069.60 ± 33.97
Cycle 6, Day 27 (n=26 NOMAC-E2 / n=15 DRSP-EE)99.51 ± 35.60133.49 ± 61.28
PrimaryEffect on Ovarian Function as Determined by Follicle Stimulating Hormone (FSH)

The parameter was measured at pre-defined study days.

Time frame:
Cycle 1, Cycle 2, Cycle 3, and Cycle 6
Reported as:
Mean · International units per liter (IU/L)
Effect on Ovarian Function as Determined by Follicle Stimulating Hormone (FSH)
International units per liter (IU/L)NOMAC-E2DRSP-EE
Cycle 1, Day 2 (n=32 NOMAC-E2 / n=16 DRSP-EE)4.29 ± 1.454.51 ± 1.14
Cycle 1, Day 5 (n=32 NOMAC-E2 / n=16 DRSP-EE)4.08 ± 1.594.23 ± 1.33
Cycle 1, Day 8 (n=32 NOMAC-E2 / n=16 DRSP-EE)3.59 ± 1.593.40 ± 1.57
Cycle 1, Day 11 (n=30 NOMAC-E2 / n=16 DRSP-EE)3.44 ± 2.072.46 ± 1.40
Cycle 1, Day 14 (n=29 NOMAC-E2 / n=16 DRSP-EE)3.06 ± 1.902.32 ± 1.71
Cycle 1, Day 18 (n=29 NOMAC-E2 / n=16 DRSP-EE)2.95 ± 1.761.91 ± 1.69
Cycle 1, Day 21 (n=30 NOMAC-E2 / n=16 DRSP-EE)2.87 ± 1.961.61 ± 1.53
Cycle 1, Day 24 (n=30 NOMAC-E2 / n=16 DRSP-EE)2.88 ± 1.994.50 ± 4.05
Cycle 1, Day 27 (n=30 NOMAC-E2 / n=16 DRSP-EE)5.42 ± 2.517.91 ± 3.95
Cycle 2, Day 2 (n=29 NOMAC-E2 / n=16 DRSP-EE)5.32 ± 2.055.48 ± 1.82
Cycle 2, Day 5 (n=29 NOMAC-E2 / n=15 DRSP-EE)4.59 ± 1.544.08 ± 1.54
Cycle 2, Day 8 (n=29 NOMAC-E2 / n=16 DRSP-EE)3.99 ± 1.712.77 ± 1.19
Cycle 2, Day 11 (n=29 NOMAC-E2 / n=16 DRSP-EE)3.47 ± 1.681.96 ± 1.13
Cycle 2, Day 14 (n=29 NOMAC-E2 / n=15 DRSP-EE)3.34 ± 2.181.44 ± 1.00
Cycle 2, Day 18 (n=28 NOMAC-E2 / n=15 DRSP-EE)3.18 ± 1.841.22 ± 0.94
Cycle 2, Day 21 (n=27 NOMAC-E2 / n=16 DRSP-EE)3.02 ± 1.641.04 ± 0.98
Cycle 2, Day 24 (n=27 NOMAC-E2 / n=16 DRSP-EE)3.05 ± 1.763.52 ± 3.51
Cycle 2, Day 27 (n=27 NOMAC-E2 / n=16 DRSP-EE)5.92 ± 2.776.99 ± 2.78
Cycle 3, Day 2 (n=27 NOMAC-E2 / n=14 DRSP-EE)6.01 ± 2.085.17 ± 1.44
Cycle 6, Day 14 (n=25 NOMAC-E2 / n=14 DRSP-EE)3.08 ± 1.881.43 ± 1.32
Cycle 6, Day 18 (n=26 NOMAC-E2 / n=15 DRSP-EE)2.82 ± 1.791.29 ± 1.28
Cycle 6, Day 21 (n=26 NOMAC-E2 / n=15 DRSP-EE)3.30 ± 2.140.92 ± 0.96
Cycle 6, Day 24 (n=26 NOMAC-E2 / n=14 DRSP-EE)2.86 ± 2.093.18 ± 3.04
Cycle 6, Day 27 (n=26 NOMAC-E2 / n=15 DRSP-EE)5.65 ± 2.576.22 ± 2.99
SecondaryAverage Number of Breakthrough Bleeding/Spotting Days

Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding/spotting was defined as any episode that occurred during the "expected non-bleeding period" that was neither an early nor a continued withdrawal bleeding. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle.

Time frame:
Every 28-day cycle for 6 cycles
Reported as:
Mean · Days
Average Number of Breakthrough Bleeding/Spotting Days
DaysNOMAC-E2DRSP-EE
Cycle 1 (n=7 NOMAC-E2; n=1 DRSP-EE)3.0 ± 2.22.0 ± NA
Cycle 2 (n=6 NOMAC-E2; n=0 DRSP-EE)2.7 ± 1.9NA ± NA
Cycle 3 (n=5 NOMAC-E2; n=0 DRSP-EE)2.2 ± 1.1NA ± NA
Cycle 4 (n=5 NOMAC-E2; n=0 DRSP-EE)4.0 ± 2.8NA ± NA
Cycle 5 (n=8 NOMAC-E2; n=0 DRSP-EE)3.5 ± 2.3NA ± NA
Cycle 6 (n=5 NOMAC-E2; n=0 DRSP-EE)3.6 ± 2.1NA ± NA
SecondaryAverage Number of Withdrawal Bleeding Days

Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Withdrawal bleeding was defined as bleeding/spotting episode that started during or continued into the "expected bleeding period". Expected bleeding period: DRSP-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle.

Time frame:
Every 28-day cycle for 6 cycles
Reported as:
Mean · Days
Average Number of Withdrawal Bleeding Days
DaysNOMAC-E2DRSP-EE
Cycle 1 (n=27 NOMAC-E2; n=16 DRSP-EE)7.2 ± 6.77.0 ± 4.7
Cycle 1 (n=25 NOMAC-E2; n=16 DRSP-EE)7.4 ± 7.55.0 ± 1.7
Cycle 3 (n=24 NOMAC-E2; n=15 DRSP-EE)4.3 ± 2.45.4 ± 1.5
Cycle 4 (n=24 NOMAC-E2; n=15 DRSP-EE)4.7 ± 1.95.3 ± 1.0
Cycle 5 (n=24 NOMAC-E2; n=15 DRSP-EE)5.5 ± 6.14.9 ± 1.1
Cycle 6 (n=22 NOMAC-E2; n=13 DRSP-EE)5.2 ± 6.33.9 ± 0.9
PrimaryEffect on Ovarian Function as Determined by Luteinizing Hormone (LH)

The parameter was measured at pre-defined study days.

Time frame:
Cycle 1, Cycle 2, Cycle 3, and Cycle 6
Reported as:
Mean · IU/L
Effect on Ovarian Function as Determined by Luteinizing Hormone (LH)
IU/LNOMAC-E2DRSP-EE
Cycle 1, Day 2 (n=32 NOMAC-E2 / n=16 DRSP-EE)3.73 ± 1.643.69 ± 1.58
Cycle 1, Day 5 (n=32 NOMAC-E2 / n=16 DRSP-EE)2.98 ± 1.494.34 ± 2.35
Cycle 1, Day 8 (n=32 NOMAC-E2 / n=16 DRSP-EE)2.50 ± 1.683.09 ± 2.36
Cycle 1, Day 11 (n=30 NOMAC-E2 / n=16 DRSP-EE)2.13 ± 1.501.89 ± 1.45
Cycle 1, Day 14 (n=29 NOMAC-E2 / n=16 DRSP-EE)1.85 ± 1.772.32 ± 2.05
Cycle 1, Day 18 (n=29 NOMAC-E2 / n=16 DRSP-EE)1.76 ± 1.411.61 ± 1.29
Cycle 1, Day 21 (n=30 NOMAC-E2 / n=16 DRSP-EE)1.45 ± 1.331.19 ± 0.86
Cycle 1, Day 24 (n=30 NOMAC-E2 / n=16 DRSP-EE)1.59 ± 1.442.63 ± 2.07
Cycle 1, Day 27 (n=30 NOMAC-E2 / n=16 DRSP-EE)3.04 ± 1.954.34 ± 2.38
Cycle 2, Day 2 (n=29 NOMAC-E2 / n=16 DRSP-EE)3.47 ± 2.204.81 ± 3.01
Cycle 2, Day 5 (n=29 NOMAC-E2 / n=15 DRSP-EE)3.04 ± 1.945.08 ± 3.21
Cycle 2, Day 8 (n=29 NOMAC-E2 / n=16 DRSP-EE)2.48 ± 1.853.33 ± 1.97
Cycle 2, Day 11 (n=29 NOMAC-E2 / n=16 DRSP-EE)2.54 ± 2.012.70 ± 2.18
Cycle 2, Day 14 (n=29 NOMAC-E2 / n=15 DRSP-EE)2.39 ± 2.171.69 ± 1.42
Cycle 2, Day 18 (n=28 NOMAC-E2 / n=15 DRSP-EE)2.05 ± 1.761.60 ± 1.31
Cycle 2, Day 21 (n=27 NOMAC-E2 / n=16 DRSP-EE)1.68 ± 1.440.97 ± 0.67
Cycle 2, Day 24 (n=27 NOMAC-E2 / n=16 DRSP-EE)1.81 ± 1.752.38 ± 2.01
Cycle 2, Day 27 (n=27 NOMAC-E2 / n=16 DRSP-EE)3.37 ± 2.903.92 ± 2.17
Cycle 3, Day 2 (n=27 NOMAC-E2 / n=14 DRSP-EE)3.71 ± 2.234.79 ± 2.67
Cycle 6, Day 14 (n=25 NOMAC-E2 / n=14 DRSP-EE)2.29 ± 1.862.15 ± 2.83
Cycle 6, Day 18 (n=26 NOMAC-E2 / n=15 DRSP-EE)1.88 ± 2.051.27 ± 1.02
Cycle 6, Day 21 (n=26 NOMAC-E2 / n=15 DRSP-EE)2.00 ± 1.681.14 ± 0.89
Cycle 6, Day 24 (n=26 NOMAC-E2 / n=14 DRSP-EE)1.85 ± 1.752.56 ± 2.12
Cycle 6, Day 27 (n=26 NOMAC-E2 / n=15 DRSP-EE)3.13 ± 2.214.03 ± 2.57

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
NOMAC-E2—1/32 (3.1%)30/32 (93.8%)
DRSP-EE—0/16 (0%)15/16 (93.8%)
Most frequent serious events
Most frequent serious events
EventNOMAC-E2DRSP-EE
Appendicitis perforatedGastrointestinal disorders1/320/16
Most frequent other events
Showing 10 of 49
Most frequent other events
EventNOMAC-E2DRSP-EE
NasopharyngitisInfections and infestations15/329/16
InfluenzaInfections and infestations5/327/16
DiarrhoeaGastrointestinal disorders11/320/16
NauseaGastrointestinal disorders8/323/16
VomitingGastrointestinal disorders2/324/16
HeadacheNervous system disorders8/324/16
Breast painReproductive system and breast disorders0/324/16
Abdominal pain lowerGastrointestinal disorders5/323/16
CystitisInfections and infestations4/323/16
Breast enlargementReproductive system and breast disorders1/323/16

Baseline characteristics

Age, Continuous
Age, Continuous(years)NOMAC-E2DRSP-EETotal
Mean22.8 ± 3.322.9 ± 4.322.8 ± 3.6
Sex: Female, Male
Sex: Female, Male(Participants)NOMAC-E2DRSP-EETotal
Female321648
Male000
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Study locations

No study locations are listed for this record.

09

References and documents

Publications

  • Duijkers IJ, Klipping C, Grob P, Korver T. Effects of a monophasic combined oral contraceptive containing nomegestrol acetate and 17 beta-oestradiol on ovarian function in comparison to a monophasic combined oral contraceptive containing drospirenone and ethinylestradiol. Eur J Contracept Reprod Health Care. 2010 Oct;15(5):314-25. doi: 10.3109/13625187.2010.504313. PubMed 20695770 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00511433
Lead sponsor
Organon and Co
Responsible party
Sponsor
First posted
Aug 3, 2007
Start date
Oct 2006
Primary completion
Jan 2008
Completion
Jan 2008
Results posted
Aug 29, 2011
Last update
Feb 9, 2022

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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