Interested in trying out a male birth control method?
Participate in a research study.
Help us develop a new
male contraceptive gel.
Contribute to discoveries that may improve health care for you and your family!
Contact Us:
Michael Massone
Study Coordinator
(310) 222-1873
Elizabeth Ruiz
Study Coordinator
(310) 222-1728
Investigator
Christina Wang, MD
Investigator, The Lundquist Institute
Professor of Medicine, David Geffen School of Medicine at UCLA
Assistant Dean, Clinical and Translational Science, David Geffen School of Medicine at UCLA
Associate Director, UCLA Clinical and Translational Science Institute at The Lundquist Institute at Harbor-UCLA Medical Center
Location:
The Lundquist Institute
1124 West Carson Street
Torrance, CA 90502
Direction: https://lundquist.org/maps-directions
.png)
We're inviting couples to take part in a clinical trial for a male contraceptive gel!
Men who wish to control their fertility currently have limited options. They have to rely on their female partner using contraceptives, use condoms, undergo vasectomy, or abstain.
This study is testing a gel as a possible new method for male family planning. It is a transparent gel applied daily to the skin of the shoulders. It aims to decrease a man’s sperm production in a reversible way without reducing sexual drive. The study also looks at the men’s compliance and the couple’s acceptance of this contraceptive method.
The study product is a combination hormone gel that contains Nestorone® and Testosterone. These hormones suppress the production of sperm to prevent the possibility of fathering a baby. Nestorone has been tested and shown to be safe and blocks the production of 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 Insitute of Health.
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.
Study Length
The study will take approximately 2 years. Men will visit the clinic approximately 31 times and their female partner approximately 10 times.
The trial has 3 phases:
Who can participate:
We're looking for couples to participate. Men and their female partners are both active participants in the study and must both consent. See the main criteria for both men and women.
The male partner must:
-
Be healthy and between 18 and 50 years (inclusive) old.
-
Be sexually active with the female partner in a stable, mutually monogamous relationship for at least 1 year.
The female partner must:
-
Be healthy and between 18 and 34 years (inclusive) old.
-
Be sexually active with the male partner in a stable, mutually monogamous relationship for at least 1 year.
-
Have regular menstrual cycles of 21-35 days.
-
Have no known infertility.
Compensation
Male Partner: You may receive up to $2,985 for your participation.
Female Partner: You may receive up to $1,600 for your participation.
Resources
ClinicalTrials.gov: NCT03452111
Specific Trial Sites
United States, California
UC Davis Health
Sacramento, California, United States, 95817
Contact: UC Davis OBGYN 916-734-6886 hs-obgynresearch@ucdavis.edu
Contact: UC Davis OBGYN 916-734-6846
Principal Investigator: Mitchell Creinin
The Lunquist Institute at Harbor-UCLA Medical Center
Torrance, California, United States, 90509
Contact: Xiaodan Han 310-341-9323 xhan@lundquist.org
Contact: Elizabeth Ruiz 310-341-9323 eruiz@lundquist.org
Principal Investigator: Christina Wang
United States, Kansas
University of Kansas
Kansas City, Kansas, United States, 66160
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Contact: Morinne Osborne 503-494-3173 osbornmo@ohsu.edu
Principal Investigator: Alison Edelman, MD
United States, Pennsylvania
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States, 19104
Contact: Andrea Morley 215-615-4202 andrea.morley@pennmedicine.upenn.edu
Contact: Nicole Clayton 215.615.4202 Nicole.clayton@pennmedicine.upenn.edu
Principal Investigator: Kurt Barnhart, MD, MSCE
United States, Virginia
Eastern Virginia Medical School-EVMS Obstetrics & Gynecology
Norfolk, Virginia, United States, 23507
Contact: Jamie Evans 757-446-7972 evansJL@EVMS.edu
Principal Investigator: David Archer
United States, Washington
University of Washington Medical Center & Health Sciences
Seattle, Washington, United States, 98195
Contact: Stephanie Page, MD, PhD 206-616-1818 page@uw.edu
Contact: Kathy Winter 206-616-0484 klwinter@uw.edu
Principal Investigator: Stephanie Page, MD, PhD
Chile
Chilean Institute of Reproductive Medicine
Santiago, Chile, 8320000
Contact: Veronica Reyes 56-2-26335887 vreyes@icmer.org
Contact: Fernanda Pinchetti 562 26328258 fpinchetti@icmer.org
Principal Investigator: Gabriela Noe, MS
Italy
University of Bologna, Italy
Bologna, Italy, 40138
Contact: Giulia Gava +390512143716 gava.giulia@hotmail.it
Contact: Silvia Cerpoini +390512143716 silviacerpolini@gmail.com
Principal Investigator: Cristina Meriggiola
Kenya
Kenyatta National Hospital
Nairobi, Kenya, 00202
Contact: Sheila Eshiwani 254722799052 seshiwanin@gmail.com
Contact: Anne Kaggiah akaggiah@gmail.com
Principal Investigator: John Kinuthia, MBChB, MPH
Sweden
Karolinska Institutet
Stockholm, Sweden
Contact: Ulrika Fundin 46(8)517 721 28 ulrika.fundin@ki.se
Contact: Anette Daberius 46(8)-517-721-28 anette.daberius@ki.se
Principal Investigator: Kristina Gemzell-Danielsson, MD
United Kingdom
University of Edinburgh
Edinburgh, United Kingdom, EH 16 4SA
Contact: Anne Saunderson 0131 242 2669 A.Saunderson@ed.ac.uk
Contact: Norma Forson 0131 242 2669 norma.forson@ed.ac.uk
Principal Investigator: Richard Anderson, MD, PhD
University of Manchester, UK
Manchester, United Kingdom, M13 9WL
Contact: Verity Natale 0161 276 3296 Verity.Natale@cmft.nhs.uk
Contact: Claudia Grant claudia.grant@mft.nhs.uk
Principal Investigator: Cheryl Fitzgerald, MD
Supression
Men will start applying the gel once every day.
Efficacy
When the man's sperm count drops to an appropriate level to prevent pregnancy, the couple will begin to use the gel as their only form of contraception for one year. The man's sperm count will be checked regularly
Recovery
Men will stop using the gel and the study team will monitor recovery of sperm count.