Sperm Suppression and Contraceptive Protection provived by Norethisterone Enantate (NET-EN) combined with Testosterone Undecanoate (TU) in healthy men.

• Conditions: The proposed study is designed to evaluate whether the combination of a progestin, norethisteroneenantate (NET-EN), and an androgen, testosterone undecanoate (TU), represents a safe and effectivemethod of male fertility regulation.; MedDRA version: 13.1Level: PTClassification code 10065589Term: Male contraceptionSystem Organ Class: 10042613 - Surgical and medical procedures

• Registration Number: EUCTR2007-005315-26-DE
• Lead Sponsor: CONRAD, Eastern Virgina Medical School

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01-23
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Inclusion criteria for male volunteers
• 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 10^6 / ml or total sperm count of = 39 x 10^6 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 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
• 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.

Inclusion criteria for the female partners
• Signed written Consent Form
• Female healthy subjects
• Ages 18-38 years, inclusive
• No tubal ligation
• Sexually active with male volunteer, with a coital frequency of 2/week, on average
• Normal reproductive state demonstrated by:
o regular menstrual cycles (no cycles that are shorter than 23 days or longer than 38 days)
by volunteer history for the past three months. If recently used steroidal contraception
see restrictions in Section 3.3.5, Screening/Enrollment Procedures, Enrollment Visit (S00).
o medical and gynaecological history without findings suggestive of impaired fertility as
judged by the P.I. (e.g. no history of pelvic inflammatory disease, endometriosis, use of hormonal contraception with the indication to regulate menses or
complications resulting from any conception/pregnancy which may adversely affect
future fertility)
o no contraindication to pregnancy
o no signs or symptoms of a sexually transmitted infection
• In a stable mutually monogamous relationship/partnership with the male volunteer 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
• 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:
• 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 Visit A
• History of allergy to any component of the study drugs

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
• Any indication of chronic use of illicit drugs or alcohol abuse

Study & Design

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