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Clinical Trial Details (PDF Generation Date :- Mon, 27 Sep 2021 09:34:08 GMT)

CTRI Number CTRI/2010/091/000225 [Registered on: 15/03/2010] - Last Modified On Post Graduate Thesis Type of Trial Type of Study Study Design Single Arm Trial Public Title of Study A to study the contraceptive efficacy of two drugs, enatate and undecanoate in healthy men Scientific Title of Sperm suppression and contraceptive protection provided by norethisterone enatate (NET-EN) Study combined with testosterone undecanate (TU) in healthy men Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Deoki Nandan Trial Coordinator (multi-center study) Designation Affiliation Address National Institute of Health and Family Welfare Munirka New Delhi DELHI 110067 India Phone 01126100057 Fax 01126101623 Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Prof.M.M.Misro Query) Designation Affiliation C0-investigator Address Department Of RBM, National Institute of Health and Family Welfare Munirka New Delhi DELHI 110067 India Phone 01126165959 Fax 01126101623 Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Prof.M.M.Misro Designation Affiliation Address Department Of RBM, National Institute of Health and Family Welfare Munirka New Delhi DELHI 110067 India Phone 01126165959

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Fax 01126101623 Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > CONRAD Primary Sponsor Primary Sponsor Details Name WHO/CONRAD Address Type of Sponsor Details of Secondary Name Address Sponsor NIL Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Prof.M.M.Misro National Institute of Department of RBM, 0116165959 Health and Family National Institute of 01126101623 Welfare Health and Family Welf [email protected] are,Munirka-110067 New Delhi DELHI Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Institutional Review Approved No Date Specified Not Available Board, NIHFW Regulatory Clearance Status Date Status from DCGI Approved/Obtained No Date Specified Health Condition / Health Type Condition Problems Studied ? Healthy male subjects Intervention / Type Name Details Comparator Agent Intervention Norethisterone enantate 200 mg/ml, every 8 weeks by Intervention Testosterone undecanoate 1000 mg/4 ml every 8 weeks By injection Comparator Agent NIL NIL Inclusion Criteria Inclusion Criteria Age From Age To Gender Details ? 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 (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

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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 Details ? 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 (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 to any component of the study drugs Method of Generating Not Applicable Random Sequence Method of Case Record Numbers Concealment Blinding/Masking Open Label Primary Outcome Outcome Timepoints Number of male participants who are rendered after 32 weeks (4 Injection visits) azoospermic/or severely oligospermic Secondary Outcome Outcome Timepoints Maintenance of suppression of spermatogenesis 56 weeks below the threshold criterion for contraception by the combined regimen, throughout the Efficacy Phase; 2. Reversibility of the regimen as determined by Within 24 weeks the return of semen concentrations to ≥ 15 million/ml or of total sperm numbers ≥ to 39 x 106, the lower reference limits (5th

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centile of the reference distribution) of a fertile population, as defined by current WHO recommendations; Target Sample Size Total Sample Size=60 Sample Size from India= Final Enrollment numbers achieved (Total)=Applicable only for Completed/Terminated trials Final Enrollment numbers achieved (India)=Applicable only for Completed/Terminated trials Phase of Trial Phase 2 Date of First No Date Specified Enrollment (India) Date of First 15/03/2010 Enrollment (Global) Estimated Duration of Years=3 Trial Months=0 Days=0 Recruitment Status of Not Yet Recruiting Trial (Global) Recruitment Status of Trial (India) Publication Details Brief Summary A prospective, phase IIb, single arm, multicentre study design will be used. The study is designed to evaluate whether the combination of a progestin, norethisterone enantate (NET-EN), and an , testosterone undecanoate (TU), represents a safe and effective method of male fertility regulation. The study consists of a Screening/Enrollment Phase lasting up to 8 weeks, a Suppression Phase of up to 26 weeks, an Efficacy Phase of up to 56 weeks, and a Recovery Phase. The study will enroll approximately 400 couples recruited at up to 10 centres. The study is expected to be completed in 3 1/2 years from the trial initiation, with data analysis continuing for another 8 to 9 months. After informed consent has been provided by each male volunteer and his female partner, he will enter a Screening/Enrollment Phase and will undergo two semen analyses, one blood draw, complete physical and andrological examinations, one urinalysis, and a digital prostate examination; female partners will be evaluated for normal reproductive function and pregnancy. When screening and baseline procedures are completed, eligible couples (n = approximately 400) will be enrolled and the male participant will enter the Suppression Phase and will receive: NET-EN 200 mg + TU 1000 mg IM every 8 weeks for up to 26 weeks (up to 4 injection visits, 2 injections at each visit). During this time, couples will use alternative contraception and the male partner will undergo regular semen analyses. Participants will be entered into the Efficacy Phase (up to 56 weeks) provided that the male partner provide 2 consecutive semen samples demonstrating sperm concentrations <1 million/ml and continue to receive: NET-EN 200 mg + TU 1000 mg IM every 8 weeks for at least 6, but nor more than 7 injection visits, 2 injections at each visit. During this phase, participants will be asked to rely only on the injections for contraception. When this phase of the trial is complete, participants will be entered into the Recovery Phase; male participants will no longer receive injections, but will be regularly followed until either their semen concentrations return to ≥ 15 million/ml or total sperm numbers ≥ return to 39 x 106, the lower reference limits (5th centile of the reference distribution) of a fertile population, as defined by current WHO recommendations. Alternative contraception will be resumed. Participants will be asked to provide information on sexual activity and the acceptability of the hormonal regimen at scheduled times throughout the study.

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