Research Center: Eastern Virginia Medical School
Location: 601 Colley Ave, Norfolk, VA 23507
Lead Researcher: David F. Archer, M.D.
IRB Committee: This study has been reviewed and approved by the Advarra Institutional Review Board

Want to help advance medical research on new contraceptive methods for men? While contraceptive methods for women are widely available, options for men have been few over the decades. Research and development for male contraceptives have been limited over the years. Luckily, some new options are being studied to solve this.

This research study seeks to investigate a new form of male birth control gel which is applied each day to the right and left upper arms and shoulders that blocks the production of male hormones needed to make sperm in men. The results of this study may help researchers develop a new self-administered, temporary, and user-friendly method of birth control for men.

Does this interest you? Read on!

• Participants will receive a new potential male contraceptive gel at no cost.
• Participants will be contributing valuable information that may help in the development of male contraceptive methods in the future.
• Participants will be compensated up to $2,195 for participating in this study. Compensation will only be provided to eligible participants following each completed visit or at the end of their participation in the study.
• Participants will be helping to advance medical research on male contraceptive methods.

• If you decide to participate in the study and later feel that you no longer wish to be part of it, you can withdraw at any time.
• Any information that you provide will be kept strictly confidential, except as required by law.
• Qualified health professionals will monitor your health as it relates to the study.

• Healthy men aged 18-50 who have healthy female partners aged 18-34
  • Must be in a stable, mutually monogamous relationship for at least 1 year and intend to remain in a relationship for the duration of the study
  • Must be sexually active with their partner
  • Must have no plans to be pregnant with partner or partner must not be pregnant during the duration of the study
• The couple must consistently use an approved method of birth control or contraception
• The couple must not be infertile
• The couple must be able to attend up to 31 study visits at the research site over approximately 2 years

The study team will explain the research study in its entirety but some details are:

• The product used in this study is a combination hormone gel that contains nestorone and testosterone. This gel is applied to the body and works by replacing the testosterone that is normally produced by the body.
  • Male participants will be given the study gel to take home after each study visit. They will need to apply the gel at about the same time each day to their right and left upper arms and shoulders.
• Participants will be asked to complete questionnaires.
• This study will consist of 4 parts:
  • Screening Phase (4-8 weeks) to see if participants are able to take part in the study.
  • Suppression Phase (estimated up to 20 weeks) where the male participant will apply the study gel to ensure that it reduces his sperm count.  The couple will use an approved highly effective method of contraception during this time.
  • Efficacy Phase (52 weeks) where the male participant will continue to apply the study gel without using another method of contraception, and the couple will rely solely on this new method of contraception. 
  • Recovery Phase (estimated 24 weeks) where the study doctor will monitor the male participant’s health and confirm that his sperm count returns to normal.  Women will use another highly effective method of contraception during this time.
• Male participants will be asked to complete a “Male Daily Study Drug Log”. The female partners will also be asked to complete diary entries and study logs.
• Male participants will be asked to provide sperm samples.
• Male participants will be asked to complete an andrological exam for testicular size.
• Participation in this study will involve the collection of blood. 

Eastern Virginia Medical School

EVMS is dedicated to serving the community that created us. They educate the next generation of exceptional medical and healthcare professionals. They provide outstanding patient care for the residents of our region. They conduct research to improve healthcare outcomes for their local community and communities the world over. Their graduates, investigators, and physicians are expanding our global influence. Learn how our impact benefits Hampton Roads.

Please note:
Due to the COVID-19 pandemic, the researchers would like to assure the participants that ensuring their and the study staff’s safety is of utmost importance.