SPERM SUPPRESSION AND CONTRACEPTIVE PROTECTION PROVIDED BY NORETHISTERONE ENANTATE (NET-EN) COMBINED WITH TESTOSTERONE UNDECANOATE (TU) IN HEALTHY MEN - ND

• Conditions: Spermatogenesis suppression for male contraception; MedDRA version: 9.1Level: LLTClassification code 10065589Term: Male contraception

• Registration Number: EUCTR2007-005315-26-IT
• Lead Sponsor: CONRAD EASTERN VIRGINIA MEDICAL SCHOO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-03
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 280

Inclusion Criteria

Inclusion criteria for male volunteers Signed written Consent Form Ages 18-45 years Normal reproductive state demonstrated by sperm concentrations and screening gonadotropin and testosterone levels Body Mass Index (BMI) between 20 and 32 kg/m² Sexually active with female partner, with a coital frequency of 2/week, on average In a stable mutually monogamous relationship/partnership with the female partner for at least 1 year and intends to remain in the relationship for the course of the study No desire for partner pregnancy within the next 2 years and willing to accept a low but unknown risk of pregnancy. Inclusion criteria for the female partners Signed written Consent Form Female healthy subjects Ages 18-35 years, inclusive No tubal ligation Sexually active with male volunteer, with a coital frequency of 2/week, on average Normal reproductive state In a stable mutually monogamous relationship/partnership with the male volunteer for at least 1 year and intends to remain in the relationship for the course of the study Not pregnant at the time of entry to the Suppression Phase No desire for pregnancy within the next 2 years and willing to accept a low but unknown risk of pregnancy.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion criteria for the male volunteers: History of prostate or testicular pathology or male infertility Diseases (including tumors) that may be affected by testosterone use or that may affect the outcome of the study Use of any disallowed medications as listed in the Investigator?s Brochure or of any drug known to affect absorption, distribution, metabolism or excretion (ADME) of testosterone within the 30 days preceding the first administration of the test compounds Use of oral anticoagulatory drugs (e.g., warfarin) within the 30 days preceding the first administration of the test compounds and during the study Implantation of a sustained-action sex hormone within 8 months of Visit A Exclusion criteria for the female partners: Participation in any other clinical trial that would affect fertility Use of DMPA 12 months prior to Visit A

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified