A Phase 3 interventional study of NOMAC-E2 and NETA-EE in Contraception, sponsored by Organon and Co. Terminated. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-20.
Sponsored by Organon and Co · Phase 3, Interventional, and Prevention
The purpose of this study was to assess the contraceptive efficacy of a nomegestrol acetate + 17ß-estradiol (NOMAC-E2) combined oral contraceptive (COC) in healthy, sexually-active American women at risk for pregnancy. Vaginal bleeding patterns of women taking NOMAC-E2 were assessed and compared to those of women taking a norethisterone acetate + ethinyl estradiol (NETA-EE) COC. The safety of NOMAC-E2 was also assessed.
Participants were randomized to receive either NOMAC-E2 or NETA-EE in a 3:1 ratio. As of Amendment 1 (which increased the sample size of the NOMAC-E2 group), the randomization ratio was adapted accordingly for participants randomized after the sample size increase.
This study was terminated early. The decision to terminate the study was based upon difficulties encountered with data collection (related to incomplete e-Diary entries) in concert with business considerations. The decision was not related to any new or unexpected safety or efficacy findings with NOMAC-E2. As a result of this early termination, none of the pre-specified efficacy endpoints were analyzed.
Organon and Co is the lead sponsor of 478 studies on the registry; none are open to participants now.
Of its 21 completed or terminated interventional studies of FDA-regulated products, 17 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28.
Drug: NOMAC-E2 · Other: Placebo
Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28.
Drug: NETA-EE · Drug: ethinylestradiol (EE) · Drug: ferrous fumarate
NOMAC-E2 film-coated oral tablets containing 2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol.
Also known as: MK-8175A, SCH 900121, Org 10486-0 (NOMAC), Org 2317 (E2)
NETA-EE film-coated oral tablets containing 1 mg norethisterone acetate and 10 μg ethinylestradiol.
Also known as: Lo Loestrin® Fe
tablet
EE 10 μg tablet
ferrous fumarate 75 mg tablet
Number of In-Treatment Pregnancies Per 100 Woman Years of Exposure (Pearl Index)
Primary Efficacy Outcome measure for this study was contraceptive efficacy, or the prevention of in-treatment pregnancy. The total incidence of in-treatment pregnancies was expressed as the Pearl Index, which is defined as the number of in-treatment pregnancies per 100 woman-years of exposure.
Time frame: Up to 1 year (13 cycles)
Percentage of Participants With an Occurrence of Breakthrough Bleeding/Spotting
Participants kept e-diaries to record their vaginal bleeding events. They were asked to record, on a daily basis, whether they experienced vaginal bleeding, which included BLEEDING or SPOTTING, at any time during a cycle other than normal menstruation while in the study. (This is also known as "breakthough" bleeding.) Vaginal bleeding that required \>=1 pad/tampon per day was classified as BLEEDING. Vaginal bleeding that did not require a pad/tampon per day was classified as SPOTTING.
Time frame: Up to 1 year (13 cycles)
Percentage of Participants With an Absence of Withdrawal Bleeding
Participants kept e-diaries to record vaginal bleeding events. They were asked to record, on a daily basis, whether vaginal bleeding was present. Absence of withdrawal bleeding was defined as no bleeding/spotting during the expected bleeding period.
Time frame: Up to 1 year (13 cycles)
Percentage of Participants Who Experienced At Least One Adverse Event
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.
Time frame: Up to 54 weeks
Number of Participants Who Experience at Least One Venous or Arterial Thrombotic/Thromboembolic Event
Time frame: Up to 54 weeks
Change From Baseline in Body Weight
Participants' body weights were measured in a consistent manner throughout the trial, using standardized equirpment. Last In-Treatment Measurement refers to a participant's end of trial visit, the timing of which differed among participants.
Time frame: Baseline and Week 52
| Milestone | NOMAC-E2 | NETA-EE |
|---|---|---|
| Started | 2553 | 620 |
| Treated | 2466 | 604 |
| Completed | 152 | 40 |
| Not completed | 2401 | 580 |
| Withdrew: Adverse event | 199 | 63 |
| Withdrew: Enrollment terminated at trial site | 2 | 0 |
| Withdrew: Lost to follow-up | 309 | 76 |
| Withdrew: Site discontinued study participation | 24 | 9 |
| Withdrew: Screen failure | 2 | 0 |
| Withdrew: Protocol violation | 7 | 0 |
| Withdrew: Pregnancy wish | 18 | 6 |
| Withdrew: Pregnancy | 45 | 10 |
| Withdrew: Physician decision | 7 | 2 |
| Withdrew: Non-compliance with study drug | 48 | 9 |
| Withdrew: Study terminated by sponsor | 1501 | 348 |
| Withdrew: Participant discontinued; drug related | 13 | 4 |
| Withdrew: Part. discontinued; unrelated to drug | 55 | 10 |
| Withdrew: Non-compliance with protocol | 39 | 15 |
| Withdrew: Participant moved | 40 | 12 |
| Withdrew: Participant withdrew consent | 28 | 9 |
| Withdrew: Withdrawal by subject | 64 | 7 |
Primary Efficacy Outcome measure for this study was contraceptive efficacy, or the prevention of in-treatment pregnancy. The total incidence of in-treatment pregnancies was expressed as the Pearl Index, which is defined as the number of in-treatment pregnancies per 100 woman-years of exposure.
No measurements were reported for this outcome.
Participants kept e-diaries to record their vaginal bleeding events. They were asked to record, on a daily basis, whether they experienced vaginal bleeding, which included BLEEDING or SPOTTING, at any time during a cycle other than normal menstruation while in the study. (This is also known as "breakthough" bleeding.) Vaginal bleeding that required \>=1 pad/tampon per day was classified as BLEEDING. Vaginal bleeding that did not require a pad/tampon per day was classified as SPOTTING.
No measurements were reported for this outcome.
Participants kept e-diaries to record vaginal bleeding events. They were asked to record, on a daily basis, whether vaginal bleeding was present. Absence of withdrawal bleeding was defined as no bleeding/spotting during the expected bleeding period.
No measurements were reported for this outcome.
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.
| Percentage of Participants | NOMAC-E2 | NETA-EE |
|---|---|---|
| Percentage of Participants Who Experienced At Least One Adverse Event | 41.2 | 45.2 |
| Participants | NOMAC-E2 | NETA-EE |
|---|---|---|
| Number of Participants Who Experience at Least One Venous or Arterial Thrombotic/Thromboembolic Event | 0 | 1 |
Participants' body weights were measured in a consistent manner throughout the trial, using standardized equirpment. Last In-Treatment Measurement refers to a participant's end of trial visit, the timing of which differed among participants.
| kilograms | NOMAC-E2 | NETA-EE |
|---|---|---|
| After Cycle 3 (n=2135; n=527) | 0.14 ± 0.14 | 0.41 ± 0.24 |
| After Cycle 6 (n=1809; n=459) | 0.64 ± 0.18 | 0.29 ± 0.28 |
| After Cycle 9 (n=1468; n=391) | 1.21 ± 0.23 | 0.32 ± 0.35 |
| After Cycle 13 (n=462; n=145) | 1.57 ± 0.29 | 0.90 ± 0.46 |
| Last In-Treatment Measurement (n=2231; n=549) | 1.39 ± 0.17 | 0.75 ± 0.29 |
Collected over Up to 54 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| NOMAC-E2 | — | 20/2,465 (0.8%) | 0/2,465 (0%) |
| NETA-EE | — | 8/604 (1.3%) | 0/604 (0%) |
| Event | NOMAC-E2 | NETA-EE |
|---|---|---|
| Internal herniaGastrointestinal disorders | 0/2465 | 1/604 |
| Bacterial pyelonephritisInfections and infestations | 0/2465 | 1/604 |
| Breast cellulitisInfections and infestations | 0/2465 | 1/604 |
| ConcussionInjury, poisoning and procedural complications | 0/2465 | 1/604 |
| Fibula fractureInjury, poisoning and procedural complications | 0/2465 | 1/604 |
| Traumatic haemothoraxInjury, poisoning and procedural complications | 0/2465 | 1/604 |
| Traumatic liver injuryInjury, poisoning and procedural complications | 0/2465 | 1/604 |
| Abortion spontaneousPregnancy, puerperium and perinatal conditions | 0/2465 | 1/604 |
| Ectopic pregnancyPregnancy, puerperium and perinatal conditions | 1/2465 | 1/604 |
| Foetal deathPregnancy, puerperium and perinatal conditions | 0/2465 | 1/604 |
All Subjects as Treated Population, which consisted of all randomized participants who took at least one dose of trial medication.
| Age, Continuous(Years) | NOMAC-E2 | NETA-EE | Total |
|---|---|---|---|
| Mean | 29.2 ± 7.6 | 29.5 ± 7.7 | 29.3 ± 7.6 |
| Sex: Female, Male(Participants) | NOMAC-E2 | NETA-EE | Total |
|---|---|---|---|
| Female | 2466 | 604 | 3070 |
| Male | 0 | 0 | 0 |
No study locations are listed for this record.
Plan to share: No
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Organon and Co