Sperm suppression and contraceptive protection provided by norethisterone enantate (NET-EN) combined with testosterone undecanoate (TU) in healthy me
- Conditions
- Male contraceptionPregnancy and Childbirth
- Registration Number
- ISRCTN07760234
- Lead Sponsor
- DP/UNFPA/WHO/World Bank - Special Programme of Research, Development and Research Training in Human Reproduction (HRP)
- Brief Summary
2016 results in https://pubmed.ncbi.nlm.nih.gov/27788052/ (added 04/01/2021)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 320
Amended 13/08/2010:
Male participants:
3.1. Sperm concentration greater than or equal to 15 million sperm/ml semen or total sperm count greater than or equal to 39 million sperm per ejaculate in two semen samples, with no gross abnormalities of sperm motility and morphology, per investigator's discretion
3.2. Screening gonadotropin (LH and FSH) and testosterone levels should be 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
Female partners:
3. Age 18 to 39 years, inclusive
All other inclusion criteria remain the same.
Current information as of 24/09/2007:
Male participants:
1. Signed written consent form
2. Male healthy volunteer
3. Normal reproductive state demonstrated by:
3.1. Sperm concentrations greater than or equal to 20 million sperm/ml semen in two semen samples with no gross abnormalities if sperm motility and morphology per investigator's discretion
3.2. Screening gonadotropin and testosterone levels within the centre's normal ranges
4. Body mass index between 20 and 32 kg/m^2
5. History and clinical examination without pathological findings relevant to the study including symptoms or signs of a sexually transmitted infection
6. Digital rectal examination of the prostate does not reveal any abnormal findings and prostate specific antigen (PSA) level is within normal range
7. Laboratory assays do not suggest the presence of any illness
8. Sexually active with female partner, with a coital frequency of twice a week, on average
9. In a stable, mutually monogamous relationship/partnership with the female partner for at least one year within first visit and intends to remain in the relationship for the course of the study
10. Willing to comply with the requirements of the protocol
11. No desire for partner pregnancy within the next two years and willing to accept a low but unknown risk of pregnancy
Female partners:
1. Signed written consent form
2. Female healthy volunteer
3. Age 18 to 35 years, inclusive
4. No tubal ligation
5. Sexually active with male volunteer, with a coital frequency of twice a week, on average
6. Normal reproductive state, demonstrated by:
6.1. Regular menstrual cycles (23 - 38 days) by volunteer history for the past three months
6.2. Medical and gynaecological history without findings suggestive of impaired fertility
6.3. No contraindication to pregnancy
6.4. No signs or symptoms of a sexually transmitted infection
7. In a stable mutually monogamous relationship/partnership with the male volunteer for at least one year and intends to remain in the relationship for the course of the study
8. Willing to comply with the requirements of the study protocol
9. Not pregnant at the time of entry into the Suppression phase
10. No desire for pregnancy within the
Amended 13/08/2010:
Male participants:
4. History of or current prostate or testicular pathology (including varicocele that is visible or palpable without Valsalva maneuver) or male infertility.
All other exclusion criteria remain the same.
Added 24/09/2007:
Male participants:
1. Participation in another clinical trial within 30 days preceding the first drug administration, or simultaneous participation in another clinical trial
2. Institutionalised or imprisoned by order of the court
3. Competition in sports which use World Anti-Doping Agency (WADA) monitoring
4. History of prostate or testicular pathology or male infertility
5. Serious organic or psychiatric disease suspected from history and.or clinical examination
6. Diseases (including tumours) that may be affected by testosterone use or that may affect the outcome of the study, for example:
6.1. Prostate disease
6.2. Past or present history, or family history, of thrombotic or embolic diseases
6.3. Hypertension requiring therapy (blood pressure [BP] greater than or equal to 140/190 mmHg)
6.4. Acute or chronic hepatic diseases
6.5. Manifest renal diseases with renal dysfunction
7. Biochemical and/or haematological laboratory values outside normal ranges, unless the investigator confirms that the deviations are of no clinical revelance
8. Any indication of chronic use of illicit drugs or alcohol abuse
9. Use of any disallowed medications or of any drug known to affect absorption, distribution, metabolism or elimination (ADME) of testosterone within the 30 days preceding the first administration of the test compounds
10. Use of oral anti-coagulatory drugs (e.g. warfarin) within the 30 days preceding the first administration of the test compounds and during the study (aspirin is allowed)
11. Implantation of a sustained-action sex hormone within 8 months of screening
12. History of allergy to any component of the study drugs
Female partners:
1. Participation in any other clinical trial that would affect fertility
2. Use of depot medroxyprogesterone acetate (DMPA) 12 months prior to screening
3. Any indication of chronic use of illicit drugs or alcohol abuse
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 1. The proportion of male participants who are rendered azoospermic and/or severely oligozoospermic (sperm concentrations less than or equal to 1 million/ml) at any point in the Suppression Phase<br> 2. 12-month contraceptive method failure rates.<br>
- Secondary Outcome Measures
Name Time Method