NES/T Male Contraceptive Gel Clinical Trial - For Couples
At The Lundquist Institute at Harbor-UCLA, we are testing a possible new method for male contraception. The medication is a transparent gel (applied daily to the skin of the man's shoulders) that is designed to temporarily stop the production of sperm.

The medication contains the hormones Nestorone® and Testosterone. These hormones suppress the production of sperm to prevent the possibility of fathering a child. Nestorone has been tested and shown to be safe and effective at blocking the production of the male hormones needed to make sperm. The testosterone in the gel works by replacing the testosterone that is normally produced by the body. 

The study gel is being developed by The Population Council, a non-profit dedicated to reproductive health, in collaboration with the National Institute of Health’s Eunice Kennedy Shriver National Institute of Child Health and Human Development

There will be no cost to you and your partner for the study medication, study doctor’s time, or procedures related to this study. Compensation for your time is provided.
Trial Overview
This trial is designed for male and female couples to participate in together. The trial is 18-24 months in length and requires monthly visits for the male partner. These visits will be done on weekday mornings at our clinic on the Harbor-UCLA Medical Center Campus in Torrance, CA. Most visits last 1 hour. The female partner will have some in-clinic visits, although most visits can be done remotely.
 
The trial is divided into 4 stages:
Couples will meet with the research team at our clinic at the Harbor-UCLA Medical Center to review the study protocol. Male participants receive a physical exam, medical history, urine, blood, and semen analysis. Female participants provide a medical history and take a pregnancy test. Once all the results are in, couples will be notified whether or not they have qualified for the study. Those who are eligible can then choose to enroll in the trial. 
During the suppression stage of the trial, the male partner will start using the study medication, but the couple will continue to use another birth control method of their choice. Men will apply the NES/T Gel once a day and will come in for monthly appointments to have their sperm count checked. When the male's sperm count is low enough (less than 1 million/mL), couples will be able to move to the next stage of the trial. The suppression stage typically lasts about 3-4 months.
Once the male's sperm count has suppressed to a low enough level, couples will be able to move to the efficacy stage. During this 12 month period, couples will stop using any birth control method or medications other than the NES/T gel. The male partner will continue to come to the clinic for monthly visits, and the female partner will need to come in once every 3 months during this stage. The research team will continue to monitor the male's sperm count to ensure it is staying at the appropriate level throughout this stage of the trial. 
During the Recovery Stage, the male partner will stop using the NES/T Gel and the couple will resume another birth control method of their choice. The male partner will continue to have monthly appointments until his sperm count returns to a normal level. This typically takes 3-4 months. Once the male's sperm count has return to a normal level couples can exit the trial.
Requirements
We're looking for sexually active heterosexual couples in the Los Angles area to participate. Men and their female partners are both active participants in the study and must both consent. See below for the main criteria for both men and women.

Inclusion criteria for the male partner:
  • In good health.
  • 18 to 50 years old.
  • In a stable, mutually monogamous relationship for at least 1 year.
  • No know infertility. 
Inclusion criteria for the female partner:
  • In good health.
  • 18 to 34 years old.
  • In a stable, mutually monogamous relationship for at least 1 year.
  • Have regular menstrual cycles of 21-35 days when not on a hormonal contraceptive.
  • No known infertility.
Not in a relationship?
Learn more about our male birth control trial for men only.
Compensation
You will be paid for time and travel because you are taking part in the study. You will be paid following the schedule below, with each visit being compensated at the listed amount. Total compensation will vary because not all participants require the same number of visits. 
Male: $3,000 (approximate total)
  • Visits 1, 3, 7, 9: $100 per visit
  • Visits 2, 4, 5, 6,8, 10: $75 per visit
  • Visits 11, 13, 16, 19, 22: $125 per visit
  • Visits 12, 14, 15, 17, 18, 20, 21, 23, 24: $80 per visit
  • Visits 26, 27, 29, 30: $85 per visit
  • Visits 25, 28, 31: $150 per visit
  • Additional or repeat visits: $100
  • Repeat blood tests only visit: $50
Female: $1,500 (approximate total)
  • Visits 1, 3, 11, 18, 25, 26: $100 per visit
  • Visits 12, 15, 21, 24: $50 per visit
  • $50 for optional onsite visits or $20 for monthly phone contacts

 
You will be paid following each completed Phase of the study. You will only be paid for your time in the study. If you stop taking part in the study for any reason, you will only be paid for the parts you do complete. If you drive more than 10 miles to our location, we will pay the Lundquist mileage rate of 57.5 cents/mile in addition to the above payment schedule.
ClinicalTrial.gov ID Number: NCT03452111
Interested? Fill out a survey to see if you are eligible.
Or contact the Trial Coordinator for more information.
Contact



Michael Massone - Trial Coordinator
michael.massone@lundquist.org
Call or text: (310) 341-9323
Our Team
The Lundquist Institute for Biomedical Innovation is a 501(c)3 independent non-profit biomedical research organization that was founded in 1952. The Institute has over more than 120 principal investigators and 400 researchers in total — MD’s, MD/Ph.D.’s, and Ph.D.’s — working on over 1,000 research studies. We are academically affiliated with the David Geffen School of Medicine at UCLA and work in partnership with the Harbor-UCLA Medical Center. Our research is funded by many sources including grants from the NIH and other government entities, Industry and teaching contracts and royalties, as well as private donors and other non-profit foundations.
Dr. Christina Wang is an internationally recognized investigator in male reproductive medicine and biology, leading the efforts to develop a safe, effective, and reversible hormonal male contraceptive. She is a Professor of Medicine and Assistant Dean in Clinical and Translational Sciences at the David Geffen School of Medicine at UCLA. She is the Associate Director of the UCLA Clinical and Translational Science Institute, and a faculty member of the Division of Endocrinology, Department of Medicine, Harbor-UCLA Medical Center and The Lundquist Institute, Torrance, California.
Check out these videos to learn more about this trial!
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Jim Sailer, Executive Director of the Population Council's Center for Biomedical Research (CBR), explains how the Council's Nestorone®/Testosterone (NES/T) transdermal male contraceptive gel works and speaks about the importance of gender equality in preventing pregnancy.
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NBC’s Simone Boyce talks with a couple that's testing out male contraception at The Lundquist Institute.
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Seeker: Right now, clinical trials are underway for a new form of birth control for men. What is it, and how does it work? 
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CBS Sacramento - Doctors at UC Davis are the latest group of medical researchers to take part in a National Institute of Health clinical study to find the next contraceptive for men.
Read about NES/T Gel in the news. 
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