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

ISRCTN	ISRCTN85103855
DOI	https://doi.org/10.1186/ISRCTN85103855
Protocol serial number	WHO/HRP ID A05104
Sponsor	UNDP/UNFPA/WHO/World Bank - Special Programme of Research, Development and Research Training in Human Reproduction (HRP)
Funder	United Nations Development Programme (UNDP)/United Nations Population Fund (UNFPA)/World Health Organization (WHO)/World Bank - Special Programme of Research, Development and Research Training in Human Reproduction (HRP), and other sources

Submission date: 19/03/2004
Registration date: 01/04/2004
Last edited: 10/10/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Kirsten Vogelsong
Scientific

World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland

Email	vogelsongk@who.int

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	1. To pilot test instruments to measure mood, sexual function and behavior of men from the general population and men participating in a trial of a hormonal contraceptive 2. To pilot instruments that evaluate the acceptability of a male hormonal method of contraception in its developmental states 3.To collect preliminary data regarding the acceptability of the hormonal regimens under investigation
Ethics approval(s)	Approved by: 1. Tthe Ethics Committee of the University of Bologna, 23/06/2000 2. HRP Scientific and Ethical Review Group, 05/09/2000 3. WHO's Secretariat Committee on Research Involving Human Subjects, 13/11/2000
Health condition(s) or problem(s) studied	Male contraception
Intervention	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 1000 mg/12 weeks for 36 weeks (n = 10) Group 2: Net-En 200 mg/six weeks plus TU 1000 mg/six weeks for 12 weeks followed by placebo/12 weeks + TU 1000 mg/12 weeks for 36 weeks (n = 10) Group 3: Net-En 200 mg/eight weeks plus TU 1000 mg/eight weeks for 48 weeks (n = 10) Group 4: Net-En 200 mg/12 weeks plus TU 1000 mg/12 weeks for 48 weeks (n = 10) Group 5: Placebo/six weeks for 12 weeks followed by placebo/12 weeks for 36 weeks (n = 10) Group 6: Untreated controls (n = 40)
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Norethisterone enanthate, testosterone undecanoate
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	1. Background characteristics of participants 2. Contraceptive history 3. Reports of partners' reactions
Completion date	01/12/2002

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target sample size at registration	90
Key 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.
Key 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.
Date of first enrolment	01/07/2000
Date of final enrolment	01/12/2002

Locations

Countries of recruitment

Italy
Switzerland

Study participating centre

World Health Organization

Geneva-27
CH-1211
Switzerland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2006		Yes	No