Male contraception study
Research type
Research Study
Full title
Clinical Evaluation of Daily Application of Nestorone® (NES) and Testosterone (T) Combination Gel for Male Contraception
IRAS ID
224226
Contact name
Richard Anderson
Contact email
Sponsor organisation
NIH - Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Eudract number
2016-002498-36
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 10 months, 30 days
Research summary
The subject of the clinical trial is an experimental gel that is being developed as a possible new method for male family planning. Currently, no safe, highly effective, reversible method of contraception is available to men who are interested in sharing the responsibility of family planning.
Men who join the study with their female sexual partner, should be healthy and between the ages of 18-50 years old. Women who join the study with their male sexual partner should be healthy and between the ages of 18-34 years old. The partners should be in a stable mutually monogamous relationship for at least 1 year prior to screening and intend to remain in the relationship for the duration of the study.
The study will take approximately two years to complete. During this time, the male partners will have to come to the clinic for approximately 31 visits, the female partners for appoximately 10 visits.
The clinical trial will be conducted at selected competence centres in reproductive medicine in Chile, Italy, Kenya, Sweden, the United Kingdom and the United States of America.
REC name
East of Scotland Research Ethics Service REC 2
REC reference
18/ES/0100
Date of REC Opinion
8 Aug 2018
REC opinion
Further Information Favourable Opinion