A Randomized, Open-Label, Comparative, Multi -Center Trial to Evaluate Contraceptive Efficacy, Cycle Control, Safety and Acceptability of a Monophasic Combined Oral Contraceptive (COC) Containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2), Compared to a Monophasic COC Containing 3 mg Drospirenone (DRSP) and 30 µg Ethinyl Estradiol (EE)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,152
- 主要终点
- Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index)
研究概览
简要总结
The primary purpose of this study is to assess contraceptive efficacy, vaginal bleeding patterns (cycle control), general safety and acceptability of the nomegestrol acetate-estradiol (NOMAC-E2) combined oral contraceptive (COC) in a large group of women aged 18-50 years.
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
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Sexually active women, at risk for pregnancy and not planning to use condoms.
- •Women in need for contraception and willing to use an oral contraceptive (OC) for 12 months (13 cycles).
- •At least 18 but not older than 50 years of age at the time of screening.
- •Body mass index (BMI) of >/= 17 and </=
- •Good physical and mental health.
- •Willing to give informed consent in writing.
排除标准
- •Contraindications for contraceptive steroids.
- •In accordance with the Summary of Product Characteristics (SmPC)/Package Insert of DRSP-EE, additional
- •contraindications related to the antimineralocorticoid activity of drospirenone
- •(conditions that predispose to hyperkalemia):
- •Renal insufficiency
- •Hepatic dysfunction
- •Adrenal insufficiency
- •An abnormal cervical smear (i.e.: dysplasia, cervical intraepithelial neoplasia [CIN],
- •Squamous Intraepithelial Lesion [SIL], carcinoma in situ, invasive carcinoma) at screening.
- •Clinically relevant abnormal laboratory result at screening as judged by the investigator.
- •Use of an injectable hormonal method of contraception; within 6 months of an injection with a 3-month duration, within 4 months of an injection with a 2-month duration, within 2 months of an injection with a 1-month duration.
- •Before spontaneous menstruation has occurred following a delivery or abortion.
- •Breastfeeding or within 2 months after stopping breastfeeding prior to the start of trial medication.
- •Present use or use within 2 months prior to the start of the trial medication of the following drugs: phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate, rifampicin, nelfinavir, ritonavir, griseofulvin, ketoconazole, sex steroids (other than pre- and posttreatment contraceptive method) and herbal remedies containing Hypericum perforatum (St John's Wort).
- •Administration of investigational drugs and/or participation in another clinical trial within 2 months prior to the start of the trial medication or during the trial period.
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 combined oral contraceptive
干预措施: NOMAC-E2 (Drug)
DRSP-EE
Drospirenone (DRSP) and Ethinyl Estradiol (EE), 3 mg DRSP and 30 mcg EE monophasic combined oral contraceptive
干预措施: DRSP-EE (Drug)
结局指标
主要结局
Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index)
时间窗: 1 year (13 cycles)
In-treatment pregnancies were pregnancies with an estimated date of conception from the day of first intake of trial medication up to and including the day of last (active or placebo) intake of trial medication extended with a maximum of two days. Each 13 cycles (28 days per cycle) of exposure constitutes a woman year. The Pearl Index was obtained by dividing the number of in-treatment pregnancies that occurred by the time (in 100 women years) that the women were under risk of becoming pregnant.
Number of In-treatment Pregnancies (With +14 Day Window) Per 100 Woman Years of Exposure (Pearl Index)
时间窗: 1 year (13 cycles)
In-treatment pregnancies were pregnancies with an estimated date of conception from the day of first intake of trial medication up to and including the day of last (active or placebo) intake of trial medication extended with a period of 14 days. Each 13 cycles (28 days per cycle) of exposure constitutes a woman year. The Pearl Index was obtained by dividing the number of in-treatment pregnancies that occurred by the time (in 100 women years) that the women were under risk of becoming pregnant.
次要结局
- Average Number of Withdrawal Bleeding/Spotting Days(Every 28-day cycle for 13 cycles (one year total))
- Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting(Every 28-day cycle for 13 cycles (one year total))
- Number of Participants With an Occurrence of Absence of Withdrawal Bleeding(Every 28-day cycle for 13 cycles (one year total))
- Number of Participants With an Occurrence of Breakthrough Bleeding(Every 28-day cycle for 13 cycles (one year total))
- Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only)(Every 28-day cycle for 13 cycles (one year total))
- Number of Participants With an Occurrence of Early Withdrawal Bleeding(Every 28-day cycle for 13 cycles (one year total))
- Number of Participants With an Occurrence of Continued Withdrawal Bleeding(Every 28-day cycle for 12 cycles)
- Average Number of Breakthrough Bleeding/Spotting Days(Every 28-day cycle for 13 cycles (one year total))