Condition category
Not Applicable
Date applied
19/03/2004
Date assigned
01/04/2004
Last edited
10/10/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Kirsten Vogelsong

ORCID ID

Contact details

World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
vogelsongk@who.int

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

WHO/HRP ID A05104

Study information

Scientific title

Acronym

Study hypothesis

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

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

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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 names

Norethisterone enanthate, testosterone undecanoate

Primary outcome measures

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 outcome measures

1. Background characteristics of participants
2. Contraceptive history
3. Reports of partners' reactions

Overall trial start date

01/07/2000

Overall trial end date

01/12/2002

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

90

Participant 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.

Recruitment start date

01/07/2000

Recruitment end date

01/12/2002

Locations

Countries of recruitment

Italy

Trial participating centre

World Health Organization
Geneva-27
CH-1211
Switzerland

Sponsor information

Organisation

UNDP/UNFPA/WHO/World Bank - Special Programme of Research, Development and Research Training in Human Reproduction (HRP)

Sponsor details

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

Sponsor type

Research organisation

Website

http://www.who.int/reproductive-health/hrp/

Funders

Funder type

Research organisation

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2006 results in: http://www.ncbi.nlm.nih.gov/pubmed/16731547

Publication citations

  1. Results

    Meriggiola MC, Cerpolini S, Bremner WJ, Mbizvo MT, Vogelsong KM, Martorana G, Pelusi G, Acceptability of an injectable male contraceptive regimen of norethisterone enanthate and testosterone undecanoate for men., Hum. Reprod., 2006, 21, 8, 2033-2040, doi: 10.1093/humrep/del094.

Additional files

Editorial Notes