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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Prof
Richard
Anderson
richard.anderson@ed.ac.uk
Prof
Richard
Anderson
richard.anderson@ed.ac.uk
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
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.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Interventional type: Drug;
You can take part if:
You may not be able to take part if:
Male Partner – Exclusion Criteria: 1. Men participating in another clinical trial involving an investigational drug within the last 30 days (or within five halflives of the investigational drug, whichever is longer) prior to the first screening visit. 2. Men not living in the catchment’s area of the study site or within a reasonable distance from the site. 3. Clinically significant abnormal findings at screening per the Investigator’s medical judgment. 4. PSA levels ≥ 4 ng/mL. 5. Abnormal serum chemistry values that may indicate clinically significant liver or kidney dysfunction. 6. Use of androgens or other anabolic steroids that may suppress gonadotropins within 6 months prior to the first screening visit. 7. Diastolic blood pressure (DBP) ≥ 85 and Systolic blood pressure (SBP) ≥ 135 mm Hg; (BP will be taken three times at approximately 5 minute intervals and the mean of the last two of the three measurements will be used to determine eligibility). 8. History of hypertension, including hypertension controlled with treatment. 9. Known history of primary testicular disease or disorders of the hypothalamic-pituitary axis. 10. Known hypersensitivity to progestins or testosterone or any excipient of the investigational product. 11. History of prostate, testicular or breast carcinoma. 12. Significant prostatic symptoms (IPSS > 15). 13. Known history of reproductive dysfunction including vasectomy or infertility. 14. Known history of significant cardiac, renal, hepatic or prostatic disease. 15. History of thromboembolic disease. 16. A serious systemic disease such as diabetes mellitus (including diabetes controlled with treatment), or HIV. 17. Current active or ongoing hepatitis infection. 18. History of untreated sleep apnea. 19. Known or suspected current alcohol dependence syndrome, chronic marijuana use, or any illicit drug use that may affect metabolism/transformation of steroid hormones and study treatment compliance. 20. Any skin condition that might interfere with absorption of gel. 21. Couples desiring fertility within the study participation period (approximately 104 weeks from screening to end of recovery). 22. PHQ9 score ≥15 or history of severe depression or other serious mental health disorder, including ongoing use of an anti-depressant. 23. Men participating in competitive sports where drug screening for prohibited substances (including anabolic steroids) is routine. Exclusion is due to the potential of testing positive for androgens that may occur from their study participation coupled with the unknown efficacy (i.e. duration of positive testing) of a single application. 24. Use of sex steroids or medications which might interfere with steroid metabolism (i.e. ketoconazole, finasteride, oral corticosteroids, dutasteride and statins). 25. Use of anticoagulants. 26. Use of medications that will interfere or interact with Nestorone or Testosterone. 27. Use of oily cosmetic skin gels/products that would prevent absorption of steroids. 28. Previous participation in this clinical trial. 29. Any site staff member with delegated study responsibilities or a family member of a site staff member with delegated study responsibilities. 30. Have issues or concerns (in the judgment of the investigator) that may compromise the safety of the subject or confound the reliability of compliance and information acquired in this study. Female Partner - Exclusion Criteria: 1. Desire to become pregnant during the study. 2. Breastfeeding. 3. Known or suspected current alcoholism or drug abuse. 4. Participation in another clinical trial involving an investigational drug within the last 30 days prior to the first screening visit. 5. Currently pregnant. 6. Known hypersensitivity to progestins or testosterone. 7. Previous participation in this clinical trial. 8. Any site staff member with delegated study responsibilities or a family member of a site staff member with delegated study responsibilities. 9. Have issues or concerns (in the judgment of the investigator) that may compromise the safety of the subject or confound the reliability of compliance and information acquired in this study.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by LOTHIAN and funded by National Institute of Child Health and Human Development (NIH NICHD) .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 41240
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