An Open-Label, Randomized, Single Center Trial in Healthy Young Women, to Evaluate the Effects of a Monophasic Combined Oral Contraceptive (COC) Containing 2.5 mg NOMAC and 1.5 mg E2 on Bone Mineral Density (BMD) Compared to a Monophasic COC Containing 0.150 mg Levonorgestrel and 0.030 mg Ethinyl Estradiol
Overview
- Phase
- Phase 3
- Intervention
- NOMAC-E2
- Conditions
- Contraception
- Sponsor
- Organon and Co
- Enrollment
- 110
- Primary Endpoint
- Mean Change From Baseline in Z-scores of the Lumbar Spine (L2-L4) and Femoral Neck
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The primary purpose of this study is to evaluate the effects of the NOMAC-E2 combined oral contraceptive (COC) on bone mineral density (BMD).
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
NOMAC-E2
Nomegestrol Acetate (NOMAC) and Estradiol (E2), 2.5 mg NOMAC and 1.5 mg E2 monophasic COC
Intervention: NOMAC-E2
LNG-EE
Levonorgestrel (LNG) and Ethinyl Estradiol (EE), 0.150 mg LNG and 0.030 mg EE monophasic COC
Intervention: LNG-EE
Outcomes
Primary Outcomes
Mean Change From Baseline in Z-scores of the Lumbar Spine (L2-L4) and Femoral Neck
Time Frame: Baseline and after cycle 26 (2 years)
BMD was measured by a Dual Energy X-ray Absorptiometry (DEXA) machine. The Z-score measures the distance of the measured BMD value from the appropriate normal age matched population mean value in units of standard deviation of this population. More negative scores indicate less BMD compared to age matched population, \& more positive scores indicate higher BMD compared to age matched population. The adjusted mean change from baseline to the after Cycle 26 visit of the Z-scores is estimated using a baseline-adjusted analysis of covariance (ANCOVA).
Secondary Outcomes
- Number of Participants With an Occurrence of Breakthrough Bleeding/ Spotting(Every 28-day cycle for 26 cycles (2 years total))
- Number of Participants With an Occurrence of Absence of Withdrawal Bleeding(Every 28-day cycle for 26 cycles (2 years total))
- Number of Participants With an Occurrence of Continued Withdrawal Bleeding(Every 28-day cycle for 26 cycles (2 years total) including one week after stopping treatment)
- Number of Participants With an Occurrence of Breakthrough Bleeding(Every 28-day cycle for 26 cycles (2 years total))
- Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only)(Every 28-day cycle for 26 cycles (2 years total))
- Number of Participants With an Occurrence of Early Withdrawal Bleeding(Every 28-day cycle for 26 cycles (2 years total))
- Average Number of Breakthrough Bleeding-Spotting Days(Every 28-day cycle for 26 cycles (2 years total))
- Average Number of Withdrawal Bleeding-spotting Days(Every 28-day cycle for 26 cycles (2 years total))
- Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index)(2 years (26 cycles))