Study of Daily Application of Nestorone® (NES) and Testosterone (T) Combination Gel for Male Contraception
- Conditions
- MenHealthyMale Contraception
- Interventions
- Registration Number
- NCT03452111
- Lead Sponsor
- Health Decisions
- Brief Summary
The long term objective is to develop a gel to be used as a male contraceptive.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 420
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Nestorone (NES) + testosterone (T) combined gel Nestorone + Testosterone Combination 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)
- Primary Outcome Measures
Name Time Method 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. 12 months
- Secondary Outcome Measures
Name Time Method Changes from baseline in Testosterone with daily use of the NES/T gel. 24 months 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 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
Trial Locations
- Locations (17)
University of Bologna, Italy
🇮🇹Bologna, Italy
Karolinska Institutet
🇸🇪Stockholm, Sweden
University of Pennsylvania Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
Spilhaus Clinical Research Site
🇿🇼Harare, Zimbabwe
University of Manchester, UK
🇬🇧Manchester, United Kingdom
University of Utah
🇺🇸Salt Lake City, Utah, United States
Comprehensive Women's Health Center
🇺🇸Denver, Colorado, United States
UC Davis Health
🇺🇸Sacramento, California, United States
University of Kansas
🇺🇸Kansas City, Kansas, United States
Chilean Institute of Reproductive Medicine
🇨🇱Santiago, Chile
University of Washington Medical Center & Health Sciences
🇺🇸Seattle, Washington, United States
Centro de Medicina Reproductiva Shady Grove Chile
🇨🇱Santiago, Vitacura, Chile
Eastern Virginia Medical School-EVMS Obstetrics & Gynecology
🇺🇸Norfolk, Virginia, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
The Lunquist Institute at Harbor-UCLA Medical Center
🇺🇸Torrance, California, United States
University of Edinburgh
🇬🇧Edinburgh, United Kingdom
Kenyatta National Hospital
🇰🇪Nairobi, Kenya