None listed
Conditions
Interventions
Intervention1: Norethisterone enantate: 200 mg/ml, every 8 weeks by injection
Intervention2: Testosterone undecanoate: 1000 mg/4 ml every 8 weeks By injection
Control Intervention1: NIL: NIL
Sponsors
WHO/CONRAD
Eligibility
Inclusion criteria
Inclusion criteria: ? Signed written Consent Form ? Male healthy subjects ? Ages 18-45 years, inclusive (or as allowed by local regulations for the lower age limit, but not less than 18 years) ? Normal reproductive state demonstrated by: o sperm concentrations ≥ 15 x 106 / ml or a total sperm count of ≥ 39 x 106 in two semen samples with no gross abnormalities of sperm motility and morphology per investigator discretion o screening gonadotropin (LH and FSH) and testosterone levels within the centre?s normal ranges, however gonadotropin levels may fall below the lower limit of the normal ranges, assuming the overall endocrine profile and semen parameters are indicative of a normal reproductive state ? Body Mass Index (BMI) between 20 and 32 kg/m² (body weight in kilograms divided by body height in meters squared) ? History and clinical examination without pathological findings relevant to the study including symptoms or signs of a sexually transmitted infection ? Digital rectal examination of the prostate does not reveal any abnormal findings and PSA level is within normal range ? Laboratory assay results do not suggest the presence of any illness ? 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 within Visit A and intends to remain in the relationship for the course of the study ? Willing to comply with the requirements of the study protocol ? No desire for partner pregnancy within the next 2 years and willing to accept a low but unknown risk of pregnancy.
Exclusion criteria
Exclusion criteria: ? Participation in another clinical trial within 30 days preceding the first drug administration, or simultaneous participation in another clinical trial ? Institutionalized or imprisoned by order of the court ? Competition in sports which use World Anti-Doping Agency (WADA) drug monitoring ? History of or current prostate or testicular pathology (including varicocele that is visible or palpable without Valsalva maneuver) or male infertility ? Serious organic or psychiatric disease suspected from history and/or clinical examination ? Diseases (including tumors) that may be affected by testosterone use or that may affect the outcome of the study, e.g.: o prostate disease o past or present history, or family history, of thrombotic or embolic diseases o hypertension requiring therapy (BP >140/90 mm Hg) o diabetes mellitus requiring therapy o acute or chronic hepatic diseases o manifest renal diseases with renal dysfunction ? Biochemical and/or hematological laboratory values outside normal ranges, unless the investigator confirms that the deviations are of no clinical relevance ? Any indication of chronic use of illicit drugs or alcohol abuse ? 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 (aspirin is allowed) ? Implantation of a sustained-action sex hormone within 8 months of the first screening visit ? History of allergy to any component of the study drugs
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Maintenance of suppression of spermatogenesis below the threshold criterion for contraception by the combined regimen, throughout the Efficacy Phase;Timepoint: 56 weeks;2. Reversibility of the regimen as determined by the return of semen concentrations to ≥ 15 million/ml or of total sperm numbers ≥ to 39 x 106, the lower reference limits (5th centile of the reference distribution) of a fertile population, as defined by current WHO recommendations;Timepoint: Within 24 weeks | — |
Primary
| Measure | Time frame |
|---|---|
| Number of male participants who are rendered azoospermic/or severely oligospermicTimepoint: after 32 weeks (4 Injection visits);The level of contraceptive protection provided by the continued administration of NET-EN and TU every 8 weeksTimepoint: during the efficacy period of 56 weeks | — |
Countries
India
Contacts
Public ContactProf.M.M.Misro
C0-investigator
Outcome results
None listed