- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01345786
Bioequivalence of Nomegestrol Acetate (NOMAC) and Estradiol (E2) in Commercial Versus Phase 3 Pivotal Clinical Batches of NOMAC-E2 Tablets (P06328)
A 2-part, Cross-over Trial of NOMAC-E2 to Assess Bioequivalence Between the Phase 3 Pivotal Clinical Batches and a Batch Prepared Using the Commercial Drug Manufacturing Process
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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".
|
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
Other Names:
|
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".
|
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
Other Names:
|
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".
|
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
Other Names:
|
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".
|
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum Observed Plasma Concentration of NOMAC (Cmax of NOMAC)
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)
|
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. |
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)
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)
|
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. |
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
Time Frame: 0 hours to time of the last measurable sample (blood samples were collected for NOMAC evaluation up to 144 hours postdose)
|
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. |
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
Time Frame: 0 hours to 72 hours
|
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. |
0 hours to 72 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Tmax of NOMAC
Time Frame: 0 hours to tmax of NOMAC (blood samples were collected for NOMAC evaluation up to 144 hours postdose)
|
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)
|
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)
|
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)
|
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
|
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
|
blood samples were collected for NOMAC evaluation up to 144 hours postdose
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- P06328
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