CompletedNCT01345786Updated Feb 9, 2022Results posted

Bioequivalence of Nomegestrol Acetate (NOMAC) and Estradiol (E2) in Commercial Versus Phase 3 Pivotal Clinical Batches of NOMAC-E2 Tablets (P06328)

A Phase 1 interventional study of Commercial NOMAC-E2 and Phase 3 NOMAC-E2 "Batch A" in Healthy Postmenopausal Females, sponsored by Organon and Co. Completed. Open to female participants aged 45 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-09.

Sponsored by Organon and Co · Phase 1, Interventional, and Prevention

Phase: Phase 1
Study type: Interventional
Enrollment: 158
Allocation: Randomized
Ages: 45 Years to 70 Years
Sex: Female

Study summary

For the contraceptive application a film-coated tablet has been developed which combines nomegestrol acetate (NOMAC) with estradiol (E2). This was an open-label, randomized, single-dose, four-way, replicate, cross-over study design conducted in 2 parallel parts at two sites, one site per study part. The primary objective of Part 1 was to assess the bioequivalence of NOMAC and E2 of the drug product manufactured using the commercial process ("commercial batch") versus the Phase 3 drug product ("Batch A"). The primary objective of Part 2 was to assess bioequivalence of NOMAC and E2 of the drug product manufactured using the commercial process ("commercial batch") versus the Phase 3 drug product ("Batch B").

Conditions studied

Healthy Postmenopausal Females

In context

Lead sponsor

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.

Who can participate

Ages eligible: 45 Years to 70 Years
Sexes eligible: Female
Accepts healthy volunteers: Yes

Eligibility criteria

Key Inclusion Criteria:

Healthy postmenopausal females between the ages of 45 and 70 years, inclusive, having a Body Mass Index (BMI) between 18 and 32, inclusive;
Free of any clinically significant disease that would interfere with the study evaluations.

Key Exclusion Criteria:

Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug;
History of any infectious disease that affected the subject's ability to participate in the trial;
History of alcohol or drug abuse in the past 2 years;
Previously received NOMAC-E2;
Current participation in another clinical study or had participated in a clinical study (eg, laboratory or clinical evaluation) within 30 days of baseline;
Smoked more than 10 cigarettes or equivalent tobacco use per day;
History of malignancy;
Contraindications for the use of contraceptive steroids;
Recent history of medication use of certain medications specified in the protocol.

Study design

Phase: Phase 1
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 158 participants (actual)

Study arms

Experimental
Commercial NOMAC-E2, Part 1
Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 1 were from "Site 1".
Drug: Commercial NOMAC-E2
Active comparator
Phase 3 NOMAC-E2, Part 1
Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program ("Batch A"), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 1 were from "Site 1".
Drug: Phase 3 NOMAC-E2 "Batch A"
Experimental
Commercial NOMAC-E2, Part 2
Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 2 were from "Site 2".
Drug: Commercial NOMAC-E2
Active comparator
Phase 3 NOMAC-E2, Part 2
Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program ("Batch B"), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 2 were from "Site 2".
Drug: Phase 3 NOMAC-E2 "Batch B"

Interventions

DrugCommercial NOMAC-E2
1 x 2.5 mg NOMAC/1.5 mg E2 fixed dose combination commercial tablet orally in the morning on Day 1 for all periods
Also known as: SCH 900121
DrugPhase 3 NOMAC-E2 "Batch A"
1 x 2.5 mg NOMAC/1.5 mg E2 fixed dose combination tablet from the Phase 3 clinical trial program ("Batch A") orally in the morning on Day 1 for all periods
Also known as: SCH900121
DrugPhase 3 NOMAC-E2 "Batch B"
1 x 2.5 mg NOMAC/1.5 mg E2 fixed dose combination tablet from the Phase 3 clinical trial program ("Batch B") orally in the morning on Day 1 for all periods
Also known as: SCH 900121

What researchers measure

Primary outcomes

Maximum Observed Plasma Concentration of NOMAC (Cmax of NOMAC)
Bioequivalence for NOMAC and E2 were tested on the primary PK parameters: Cmax, AUC(infinity), and AUClast for NOMAC; and baseline adjusted AUC72 and Cmax for E2. Blood samples for pharmacokinetic (PK) evaluation of NOMAC were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 144 hours postdose Day 1.
Time frame: 0 hours to time of maximum observed plasma concentration of NOMAC (tmax of NOMAC) (blood samples were collected for NOMAC evaluation up to 144 hours postdose)
Baseline Corrected Maximum Observed Serum Concentration of E2 (Cmax of E2)
Bioequivalence for NOMAC and E2 were tested on the primary PK parameters: Cmax, AUC(infinity), and AUClast for NOMAC; and baseline adjusted AUC72 and Cmax for E2. Blood samples for PK evaluation of E2 were collected predose (-1, -0.5, and 0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdose Day 1; multiple predose samples were needed to correct for endogenous levels.
Time frame: 0 hours to time of maximum observed serum concentration of E2 (tmax of E2) (blood samples were collected for E2 evaluation up to 96 hours postdose)
Area Under the Concentration-time Curve From Time 0 to the Time of the Last Measurable Sample (AUC Last) and Area Under the Concentration-time Curve From Time 0 to Infinity (AUC Infinity) for NOMAC
Bioequivalence for NOMAC and E2 were tested on the primary PK parameters: Cmax, AUC(infinity), and AUClast for NOMAC; and baseline adjusted AUC72 and Cmax for E2. AUClast is the AUC from time 0 to the time of the final quantifiable sample. AUC infinity is the AUC from time 0 to infinity. Blood samples for PK evaluation of NOMAC were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 144 hours postdose Day 1.
Time frame: 0 hours to time of the last measurable sample (blood samples were collected for NOMAC evaluation up to 144 hours postdose)
Baseline Corrected Area Under the Concentration-time Curve From Time 0 to 72 Hours (AUC72) for E2
Bioequivalence for NOMAC and E2 were tested on the primary PK parameters: Cmax, AUC(infinity), and AUClast for NOMAC; and baseline adjusted AUC72 and Cmax for E2. AUC72 is the AUC from time 0 to 72 hours. Blood samples for PK evaluation of E2 were collected predose (-1, -0.5, and 0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdose Day 1; multiple predose samples were needed to correct for endogenous levels.
Time frame: 0 hours to 72 hours

Secondary outcomes

Tmax of NOMAC
Time frame: 0 hours to tmax of NOMAC (blood samples were collected for NOMAC evaluation up to 144 hours postdose)
Tmax of E2
Time frame: 0 hours to tmax of E2 (blood samples were collected for E2 evaluation up to 96 hours postdose)
Terminal Phase Half Life (t1/2) of NOMAC
Time frame: 0 hours to t1/2 (blood samples were collected for NOMAC evaluation up to 144 hours postdose)
t1/2 of E2
Time frame: 0 hours to t1/2 (blood samples were collected for E2 evaluation up to 96 hours postdose)
Clearance (Calculated for NOMAC Only)
Time frame: blood samples were collected for NOMAC evaluation up to 144 hours postdose
Volume of Distribution (Calculated for NOMAC Only)
Time frame: blood samples were collected for NOMAC evaluation up to 144 hours postdose

Results

Posted Aug 29, 2011

Participant flow

Participant flow — Overall Study
Milestone	Part 1 - Sequence 1	Part 1 - Sequence 2	Part 2 - Sequence 1	Part 2 - Sequence 2
Started	41	41	38	38
Treated	41	41	37	37
Completed	35	33	33	35
Not completed	6	8	5	3
Withdrew: Adverse event	0	1	3	1
Withdrew: Subject withdrew consent	2	2	1	0
Withdrew: Noncompliance with protocol	1	0	1	0
Withdrew: Administrative	3	5	0	0
Withdrew: Lost to follow-up	0	0	0	2

Outcome measures

PrimaryMaximum Observed Plasma Concentration of NOMAC (Cmax of NOMAC)

Bioequivalence for NOMAC and E2 were tested on the primary PK parameters: Cmax, AUC(infinity), and AUClast for NOMAC; and baseline adjusted AUC72 and Cmax for E2. Blood samples for pharmacokinetic (PK) evaluation of NOMAC were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 144 hours postdose Day 1.

Time frame:: 0 hours to time of maximum observed plasma concentration of NOMAC (tmax of NOMAC) (blood samples were collected for NOMAC evaluation up to 144 hours postdose)
Reported as:: Mean · ng/mL

Maximum Observed Plasma Concentration of NOMAC (Cmax of NOMAC)
ng/mL	Commercial NOMAC-E2, Part 1	Phase 3 NOMAC-E2, Part 1	Commercial NOMAC-E2, Part 2	Phase 3 NOMAC-E2, Part 2
Maximum Observed Plasma Concentration of NOMAC (Cmax of NOMAC)	6.22 (1.06 to 13.3)	4.51 (1.72 to 11.6)	8.03 (3.44 to 14.4)	7.20 (2.70 to 12.6)

Statistical analysis

Commercial NOMAC-E2, Part 1 vs Phase 3 NOMAC-E2, Part 1 · Ratio (test/ref %): 137.5 · 90% CI 131 to 144.4Commercial Batch Test / Phase 3 Batch Reference.
Commercial NOMAC-E2, Part 2 vs Phase 3 NOMAC-E2, Part 2 · Ratio (test/ref %): 111.8 · 90% CI 107.5 to 116.4Commercial Batch Test / Phase 3 Batch Reference.

PrimaryBaseline Corrected Maximum Observed Serum Concentration of E2 (Cmax of E2)

Bioequivalence for NOMAC and E2 were tested on the primary PK parameters: Cmax, AUC(infinity), and AUClast for NOMAC; and baseline adjusted AUC72 and Cmax for E2. Blood samples for PK evaluation of E2 were collected predose (-1, -0.5, and 0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdose Day 1; multiple predose samples were needed to correct for endogenous levels.

Time frame:: 0 hours to time of maximum observed serum concentration of E2 (tmax of E2) (blood samples were collected for E2 evaluation up to 96 hours postdose)
Reported as:: Mean · pg/mL

Baseline Corrected Maximum Observed Serum Concentration of E2 (Cmax of E2)
pg/mL	Commercial NOMAC-E2, Part 1	Phase 3 NOMAC-E2, Part 1	Commercial NOMAC-E2, Part 2	Phase 3 NOMAC-E2, Part 2
Baseline Corrected Maximum Observed Serum Concentration of E2 (Cmax of E2)	56.1 (10.2 to 1255)	45.1 (9.76 to 324)	44.4 (14.1 to 347)	41.5 (19.8 to 133)

Statistical analysis

Commercial NOMAC-E2, Part 1 vs Phase 3 NOMAC-E2, Part 1 · Ratio (test/ref %): 107.3 · 90% CI 99 to 116.4Commercial Batch Test / Phase 3 Batch Reference.
Commercial NOMAC-E2, Part 2 vs Phase 3 NOMAC-E2, Part 2 · Ratio (test/ref %): 103.6 · 90% CI 99.2 to 108.2Commercial Batch Test / Phase 3 Batch Reference. In addition to the participants/profiles excluded, 1 participant from the Phase 3 Batch Reference group did not contribute to this comparison.

PrimaryArea Under the Concentration-time Curve From Time 0 to the Time of the Last Measurable Sample (AUC Last) and Area Under the Concentration-time Curve From Time 0 to Infinity (AUC Infinity) for NOMAC

Bioequivalence for NOMAC and E2 were tested on the primary PK parameters: Cmax, AUC(infinity), and AUClast for NOMAC; and baseline adjusted AUC72 and Cmax for E2. AUClast is the AUC from time 0 to the time of the final quantifiable sample. AUC infinity is the AUC from time 0 to infinity. Blood samples for PK evaluation of NOMAC were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 144 hours postdose Day 1.

Time frame:: 0 hours to time of the last measurable sample (blood samples were collected for NOMAC evaluation up to 144 hours postdose)
Reported as:: Mean · ng*h/mL

Area Under the Concentration-time Curve From Time 0 to the Time of the Last Measurable Sample (AUC Last) and Area Under the Concentration-time Curve From Time 0 to Infinity (AUC Infinity) for NOMAC
ng*h/mL	Commercial NOMAC-E2, Part 1	Phase 3 NOMAC-E2, Part 1	Commercial NOMAC-E2, Part 2	Phase 3 NOMAC-E2, Part 2
AUC last	87.3 (9.71 to 151)	78.1 (33.5 to 148)	109 (45.4 to 207)	106 (35.5 to 194)
AUC infinity	102 (13.6 to 182)	93.3 (42.4 to 200)	134 (49.2 to 299)	131 (39.4 to 262)

Statistical analysis

Commercial NOMAC-E2, Part 1 vs Phase 3 NOMAC-E2, Part 1 · Ratio (test/ref %): 110.0 · 90% CI 106.4 to 113.7Commercial Batch Test / Phase 3 Batch Reference.
Commercial NOMAC-E2, Part 2 vs Phase 3 NOMAC-E2, Part 2 · Ratio (test/ref %): 103.3 · 90% CI 100.9 to 105.7Commercial Batch Test / Phase 3 Batch Reference
Commercial NOMAC-E2, Part 1 vs Phase 3 NOMAC-E2, Part 1 · Ratio (test/ref %): 108.1 · 90% CI 104.7 to 111.6Commercial Batch Test / Phase 3 Batch Reference.
Commercial NOMAC-E2, Part 2 vs Phase 3 NOMAC-E2, Part 2 · Ratio (test/ref %): 103.1 · 90% CI 100.5 to 105.8Commercial Batch Test / Phase 3 Batch Reference

PrimaryBaseline Corrected Area Under the Concentration-time Curve From Time 0 to 72 Hours (AUC72) for E2

Bioequivalence for NOMAC and E2 were tested on the primary PK parameters: Cmax, AUC(infinity), and AUClast for NOMAC; and baseline adjusted AUC72 and Cmax for E2. AUC72 is the AUC from time 0 to 72 hours. Blood samples for PK evaluation of E2 were collected predose (-1, -0.5, and 0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdose Day 1; multiple predose samples were needed to correct for endogenous levels.

Time frame:: 0 hours to 72 hours
Reported as:: Mean · pg*h/mL

Baseline Corrected Area Under the Concentration-time Curve From Time 0 to 72 Hours (AUC72) for E2
pg*h/mL	Commercial NOMAC-E2, Part 1	Phase 3 NOMAC-E2, Part 1	Commercial NOMAC-E2, Part 2	Phase 3 NOMAC-E2, Part 2
Baseline Corrected Area Under the Concentration-time Curve From Time 0 to 72 Hours (AUC72) for E2	1315 (184 to 3132)	1278 (140 to 3481)	1359 (335 to 2813)	1342 (297 to 3059)

Statistical analysis

Commercial NOMAC-E2, Part 1 vs Phase 3 NOMAC-E2, Part 1 · Ratio (test/ref %): 101.5 · 90% CI 96.7 to 106.4Commercial Batch Test / Phase 3 Batch Reference.
Commercial NOMAC-E2, Part 2 vs Phase 3 NOMAC-E2, Part 2 · Ratio (test/ref %): 101.3 · 90% CI 98.1 to 104.7Commercial Batch Test / Phase 3 Batch Reference. In addition to the participants/profiles excluded, 1 participant from the Phase 3 Batch Reference group did not contribute to this comparison.

SecondaryTmax of NOMAC

Time frame:: 0 hours to tmax of NOMAC (blood samples were collected for NOMAC evaluation up to 144 hours postdose)
Reported as:: Median · hours

Tmax of NOMAC
hours	Commercial NOMAC-E2, Part 1	Phase 3 NOMAC-E2, Part 1	Commercial NOMAC-E2, Part 2	Phase 3 NOMAC-E2, Part 2
Tmax of NOMAC	2 (0.5 to 6)	2 (1 to 6)	2 (1 to 6)	2 (1 to 6)

SecondaryTmax of E2

Time frame:: 0 hours to tmax of E2 (blood samples were collected for E2 evaluation up to 96 hours postdose)
Reported as:: Median · hours

Tmax of E2
hours	Commercial NOMAC-E2, Part 1	Phase 3 NOMAC-E2, Part 1	Commercial NOMAC-E2, Part 2	Phase 3 NOMAC-E2, Part 2
Tmax of E2	6.02 (0.5 to 96)	8 (0.5 to 96)	8 (0.5 to 96)	8 (0.5 to 24)

SecondaryTerminal Phase Half Life (t1/2) of NOMAC

Time frame:: 0 hours to t1/2 (blood samples were collected for NOMAC evaluation up to 144 hours postdose)
Reported as:: Mean · hours

Terminal Phase Half Life (t1/2) of NOMAC
hours	Commercial NOMAC-E2, Part 1	Phase 3 NOMAC-E2, Part 1	Commercial NOMAC-E2, Part 2	Phase 3 NOMAC-E2, Part 2
Terminal Phase Half Life (t1/2) of NOMAC	58.5 (17.3 to 137)	61 (19.4 to 278)	70.8 (23.5 to 201)	69.9 (23.4 to 153)

Secondaryt1/2 of E2

Time frame:: 0 hours to t1/2 (blood samples were collected for E2 evaluation up to 96 hours postdose)
Reported as:: Mean · hours

t1/2 of E2
hours	Commercial NOMAC-E2, Part 1	Phase 3 NOMAC-E2, Part 1	Commercial NOMAC-E2, Part 2	Phase 3 NOMAC-E2, Part 2
t1/2 of E2	39.9 (8.3 to 855)	39.1 (11.2 to 853)	33.1 (9.02 to 94.8)	34.6 (7.13 to 128)

SecondaryClearance (Calculated for NOMAC Only)

Time frame:: blood samples were collected for NOMAC evaluation up to 144 hours postdose
Reported as:: Mean · L/h

Clearance (Calculated for NOMAC Only)
L/h	Commercial NOMAC-E2, Part 1	Phase 3 NOMAC-E2, Part 1	Commercial NOMAC-E2, Part 2	Phase 3 NOMAC-E2, Part 2
Clearance (Calculated for NOMAC Only)	28.3 ± 16.1	29.9 ± 9.68	21.1 ± 7.96	22.1 ± 9.37

SecondaryVolume of Distribution (Calculated for NOMAC Only)

Time frame:: blood samples were collected for NOMAC evaluation up to 144 hours postdose
Reported as:: Mean · L

Volume of Distribution (Calculated for NOMAC Only)
L	Commercial NOMAC-E2, Part 1	Phase 3 NOMAC-E2, Part 1	Commercial NOMAC-E2, Part 2	Phase 3 NOMAC-E2, Part 2
Volume of Distribution (Calculated for NOMAC Only)	2208 ± 886	2445 ± 906	1988 ± 631	2061 ± 673

Adverse events

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

Adverse event summary by group
Group	Deaths	Serious	Other
Commercial NOMAC-E2, Part 1	—	0/80 (0%)	44/80 (55%)
Phase 3 NOMAC-E2, Part 1	—	0/77 (0%)	35/77 (45.5%)
Commercial NOMAC-E2, Part 2	—	0/72 (0%)	36/72 (50%)
Phase 3 NOMAC-E2, Part 2	—	0/72 (0%)	35/72 (48.6%)

Most frequent other events

Showing 10 of 14

Most frequent other events
Event	Commercial NOMAC-E2, Part 1	Phase 3 NOMAC-E2, Part 1	Commercial NOMAC-E2, Part 2	Phase 3 NOMAC-E2, Part 2
HeadacheNervous system disorders	15/80	14/77	12/72	13/72
Hot flushVascular disorders	14/80	8/77	9/72	8/72
AcneSkin and subcutaneous tissue disorders	2/80	0/77	8/72	12/72
ConstipationGastrointestinal disorders	5/80	1/77	8/72	8/72
Pelvic painReproductive system and breast disorders	0/80	1/77	3/72	8/72
NauseaGastrointestinal disorders	5/80	7/77	3/72	1/72
Back painMusculoskeletal and connective tissue disorders	3/80	2/77	3/72	6/72
CoughRespiratory, thoracic and mediastinal disorders	1/80	1/77	5/72	1/72
DizzinessNervous system disorders	3/80	5/77	0/72	1/72
Oropharyngeal painRespiratory, thoracic and mediastinal disorders	1/80	5/77	2/72	4/72

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Part 1 - Sequence 1	Part 1 - Sequence 2	Part 2 - Sequence 1	Part 2 - Sequence 2	Total
Mean	55.3 (47 to 65)	55.5 (45 to 70)	55.9 (45 to 66)	56.5 (46 to 70)	55.78 (45 to 70)

Sex: Female, Male
Sex: Female, Male(Participants)	Part 1 - Sequence 1	Part 1 - Sequence 2	Part 2 - Sequence 1	Part 2 - Sequence 2	Total
Female	41	41	37	37	156
Male	0	0	0	0	0

Study locations

No study locations are listed for this record.

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 ↗

Registry details

Key details

Study ID: NCT01345786
Lead sponsor: Organon and Co
Responsible party: Sponsor
First posted: May 2, 2011
Start date: Nov 2009
Primary completion: Jun 2010
Completion: Jun 2010
Results posted: Aug 29, 2011
Last update: Feb 9, 2022

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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