Assessing acceptability and sexual behaviour during male contraception: mood, behavior and user's perspectives related to sperm suppression with norethisterone enanthate (NET-EN) plus testosterone undecanoate (TU) in normal men

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN85103855

Enrollment

Registered

2004-04-01

Start date

2000-07-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Male contraception Not Applicable Contraception

Interventions

Pre-treatment control period for 4-6 weeks

then treatment for 48 weeks

and a post-treatment recovery period of at least 18 weeks. Treatment groups are: Group 1: Net-En 200 mg/six weeks plus TU 1000 mg/six weeks for 12 weeks followed by Net-En 200 mg/12 weeks plus TU 100

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 10/09/2007: Male participants were recruited according the the recruitment strategy, inclusion criteria and exclusion criteria outlined on page 13 of clinical protocol number 303923 "NET-EN plus TU for male contraception" The World Health Organization did not support the clinical trial, but sponsored this acceptability component. Previous inclusion criteria: Same as those for the protocol for the clinical evaluation of the safety and efficacy of the hormonal regimens. The clinical component is supported by the private sector and supported by the World Health Organization (WHO) Department of Reproductive Health and Research; therefore, we do not have access to the protocol.

Exclusion criteria

Exclusion criteria: Male participants were recruited according to the recruitment strategy, inclusion criteria and exclusion criteria outlined on page 13 of clinical protocol number 303923 "NET-EN plus TU for male contraception" The World Health Organization did not support the clinical trial, but sponsored this acceptability component.

Design outcomes

Primary

Measure	Time frame
Current primary outcome measures as of 10/09/2007: 1. Attitudes towards contraception 2. Motivation to participate in the clinical trial 3. Reactions to the various treatment regimens 4. Overall assessment of the method 5. Reports of physical status, mood, sexual function and behaviour Previous primary outcome measures: 1. Socio-demographic and economic profile of study participants 2. Motivating factors for participation in the trial 3. Contraceptive history of participant and partner 4. Side effects experienced during the study 5. Measurements of sexual function 6. Measurements of aggression, irritability, and other mood states 7. Measurement of user's perspectives and acceptability Follow-up duration for primary endpoints: 72 - 74 weeks, including control (baseline) period.	—

Measure

Time frame

Current primary outcome measures as of 10/09/2007: 1. Attitudes towards contraception 2. Motivation to participate in the clinical trial 3. Reactions to the various treatment regimens 4. Overall assessment of the method 5. Reports of physical status, mood, sexual function and behaviour Previous primary outcome measures: 1. Socio-demographic and economic profile of study participants 2. Motivating factors for participation in the trial 3. Contraceptive history of participant and partner 4. Side effects experienced during the study 5. Measurements of sexual function 6. Measurements of aggression, irritability, and other mood states 7. Measurement of user's perspectives and acceptability Follow-up duration for primary endpoints: 72 - 74 weeks, including control (baseline) period.

—

Secondary

Measure	Time frame
1. Background characteristics of participants 2. Contraceptive history 3. Reports of partners' reactions	—

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026