Join a research study of a potential new form of male birth control

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Please answer a few questions to see if you may qualify.
Have questions? Please contact the study coordinator Obstetrics and Gynecology Research at hs-obgynresearch@ucdavis.edu or call (916) 655-0986
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  1. *1. Are you currently sexually active with a person of the opposite sex?
  2. *2. Are you the male or female partner?
  3. *3. How old are you?
  4. *4. How old is your partner?
  5. 5. How much does the male partner weigh (lbs)? If you are not sure, then answer "not sure."
  6. *6. How tall is the male partner (ft and in)? If you are not sure, then answer "not sure."
  7. *7. Do you or your partner have any history of infertility?
  8. *8. Does the female partner have regular periods (every 21-35 days)?
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Couples are invited to participate in this two year study.
Age: males age 18-50; females age 18-34
Healthy Volunteers: Yes
Keywords: male contraceptive, couples, male birth control, birth control
Type: Drug study, Phase 2
Target:
12 Participants
Investigator:
Description
This study is testing a new potential male hormonal birth control. The hormones are delivered in a gel that the male partner will use every morning. The gel has two hormones. The first one is called Nestorone®. Nestorone is also used in women’s birth control in a currently available ring. In the woman, this hormone blocks the ovary from making eggs. In this study, we expect Nestorone to act in a similar way in the man – to block the testes from making sperm. Nestorone has been tested so far in almost 300 men in four prior studies with no major safety concerns seen. The second hormone is testosterone. If a man uses Nestorone to block the testes, he will also stop making testosterone. So, we need to give him that hormone back so he can feel normal and also have erections.

For this study we are looking for male and female partners to test the how well the study gel works to prevent pregnancy for one year. We are also testing the safety and side effects of the gel.

Both the male and female partner must both consent to take part in this study. The study has three phases. In the first phase, the man uses the study gel and the woman must continue to use contraception while we test the man’s sperm count until he is no longer making enough sperm to cause pregnancy. After that, the female partner stops her contraception and both partners begin the second phase, in which the study gel will be the only method of contraception. There will be a low but unknown risk of pregnancy during this time. After one year, the man will stop using the study gel and another contraceptive will need to be started if there is no desire for pregnancy. We will follow the man’s sperm count until it is normal again. Overall, the study will take approximately two years to complete.

You and your partner must be willing to use another effective method of birth control in the first phase and use the study gel during the second phase.
This study requires

Male partners will come into the clinic for about 31 visits and receive a phone contact on weeks that do not require a clinic visit.

Female partners will come into the clinic for about 10 visits, and have 16 additional phone contacts.

Total time in the study will be approximately two years, including pre-treatment visits and all follow-up. The study treatment phase will last 12 months.

Who can participate

Inclusion criteria: good general overall health, males age 18-50 years, females age 18-34, females with a regular menstrual cycle 21-35 days in duration when not using hormonal contraception

Exclusion criteria: plans for pregnancy during the study, males with history of fertility issues

Compensation
Couples may receive up to $4700 for participating. This money is paid to cover time and travel during the study. The amount you receive will depend on how many study visits you each attend.
Resources
UC Davis IRB: 1576437
ClinicalTrials.gov: NCT03452111
Schedule
Study duration and period
For male partners: 31 visits and weekly phone calls over two years. For female partners: 10 visits and 16 phone calls over two years.
Location
UC Davis
4860 Y Street
Suite 2500
Sacramento, CA 95817
Contact
Obstetrics and Gynecology Research
Research Topic
Conditions:
  • Healthy women
  • male contraception
  • healthy men

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


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