Clinical Evaluation of Daily Application of Nestorone® (NES) and Testosterone (T) Combination Gel for Male Contraception
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 420
- 试验地点
- 17
- 主要终点
- Contraceptive efficacy provided by daily application of NES/T gel for 52 wks during the efficacy phase of the study determined using Kaplan-Meier methods to estimate the 12-mth cumulative pregnancy probability in the efficacy(evaluable cycles)population.
研究概览
简要总结
The long term objective is to develop a gel to be used as a male contraceptive.
详细描述
This is a prospective, phase IIb, open label, single arm, multicenter study. The study protocol consists of a screening phase lasting 4 to 8 weeks, a suppression phase estimated up to 20 weeks, a 52-week maintenance/efficacy phase, and a 24-week (estimated) recovery phase.
The study will involve approximately 420 couples recruited throughout the CCTN that meet eligibility criteria. Approximately fifteen sites propose to enroll up to 420 couples (about 30 to 60 couples per site) with a goal of obtaining 200 couples completing the contraceptive efficacy phase of the study. The study has four phases (screening phase, suppression phase, efficacy phase and recovery phase) with monthly visits to provide the male participants with the NES/T gel, to encourage adherence, to monitor for possible side effects, and to quantify semen parameters. The female partner will be contacted monthly and come in for a visit every three months. Male subjects will be treated and followed as outpatients, along with their participating female partner.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 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
Nestorone (NES) + testosterone (T) combined gel
A combination Gel with Nestorone® (NES) and Testosterone (T) applied transdermally (NES/T gel). The amount of gel to be applied daily will be approximately 5 mL in volume (2.5 mL to each shoulder and upper arm per day). This daily gel volume will contain approximately 62 mg or 74 mg of T of which 6.2 mg of T with the original dose (Cohort A) and about 7.4mg of T with the second dose (Cohort B) will be absorbed per day (10% skin absorption)
干预措施: Nestorone + Testosterone Combination Gel (Drug)
结局指标
主要结局
Contraceptive efficacy provided by daily application of NES/T gel for 52 wks during the efficacy phase of the study determined using Kaplan-Meier methods to estimate the 12-mth cumulative pregnancy probability in the efficacy(evaluable cycles)population.
时间窗: 12 months
次要结局
- Suppression of spermatogenesis induced by daily use of the NES/T gel as assessed by semen analyses using number of subjects with sperm concentration <1 million (M)/mL during the suppression phase of the study.(20 weeks)
- Maintenance of suppression of spermatogensis induced by daily use of the NES/T gel as assessed by semen analyses using number of subjects with sperm concentration <1 million (M)/mL during the 52 week efficacy phase of the study.(52 weeks)
- Changes from baseline in Follicle Stimulating Hormone (FSH) with daily use of the NES/T gel.(24 months)
- Changes from baseline in Luteinizing Hormone (LH) with daily use of the NES/T gel.(24 months)
- Changes from baseline in Sex Hormone Binding Globulin (SHBG) with daily use of the NES/T gel.(24 months)
- Changes from baseline in Testosterone with daily use of the NES/T gel.(24 months)
- Changes from baseline in Nestorone with daily use of the NES/T gel.(24 months)
- Incidence of treatment emergent adverse events with daily use of the NES/T gel.(24 months)
- Changes from baseline in sodium with daily use of the NES/T gel.(24 months)
- Changes from baseline in potassium with daily use of the NES/T gel.(24 months)
- Changes from baseline in chloride with daily use of the NES/T gel.(24 months)
- Changes from baseline in bicarbonate with daily use of the NES/T gel.(24 months)
- Changes from baseline in fasting glucose with daily use of the NES/T gel.(24 months)
- Changes from baseline in blood urea nitrogen with daily use of the NES/T gel.(24 months)
- Changes from baseline in creatinine with daily use of the NES/T gel.(24 months)
- Changes from baseline in calcium with daily use of the NES/T gel.(24 months)
- Changes from baseline in total bilirubin with daily use of the NES/T gel.(24 months)
- Changes from baseline in alkaline phosphatase with daily use of the NES/T gel.(24 months)
- Changes from baseline in alanine aminotransferase with daily use of the NES/T gel.(24 months)
- Changes from baseline in aspartate transaminase with daily use of the NES/T gel.(24 months)
- Changes from baseline in albumin with daily use of the NES/T gel.(24 months)
- Changes from baseline in mood with daily use of the NES/T gel using the Patient Health Questionnaire-9.(24 months)
- Changes from baseline in sexual function with daily use of the NES/T gel using the psychosexual daily questionnaire.(24 months)
- Changes from baseline in prostate function with daily use of NES/T gel using the International Prostate Symptom Score.(24 months)
- Acceptability of NES/T gel as a contraceptive among male and female participants using the acceptability questionnaires.(24 months)
- Length of time to recovery of spermatogenesis after daily use of NES/T gel as assessed by sperm concentration > 15 million (M)/mL during the recovery phase.(24 weeks)
研究者
Kimberly Myer
Senior Program Director, NICHD
Health Decisions