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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 110
- 主要终点
- Mean Change From Baseline in Z-scores of the Lumbar Spine (L2-L4) and Femoral Neck
研究概览
简要总结
The primary purpose of this study is to evaluate the effects of the NOMAC-E2 combined oral contraceptive (COC) on bone mineral density (BMD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
NOMAC-E2
Nomegestrol Acetate (NOMAC) and Estradiol (E2), 2.5 mg NOMAC and 1.5 mg E2 monophasic COC
干预措施: NOMAC-E2 (Drug)
LNG-EE
Levonorgestrel (LNG) and Ethinyl Estradiol (EE), 0.150 mg LNG and 0.030 mg EE monophasic COC
干预措施: LNG-EE (Drug)
结局指标
主要结局
Mean Change From Baseline in Z-scores of the Lumbar Spine (L2-L4) and Femoral Neck
时间窗: 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).
次要结局
- 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))