We are no longer recruiting volunteers for this particular study. Please call our office at (860) 443-4567, for information about similar upcoming clinical research studies

 

Clinical Trial for Women who Experience Sexual Dysfunction

Following Hysterectomy with Removal of the Ovaries

 

 

Who should participate:

 

This study is for women who remain sexually active after hysterectomy despite experiencing a decrease in sexual desire, arousal or satisfaction.

 

Testosterone is a natural hormone produced in both men and women, and it is thought to play a role in normal sexual function. The ovaries are a major source of testosterone in women, and testosterone levels decline with removal of the ovaries. This study is for women who feel that their decreased sexual interest, arousal or satisfaction has developed as a result of hysterectomy with removal of their ovaries.

 

Study Medication:

 

Ø       This is a study of an investigational gel form of testosterone which is applied to the skin.

 

 

Basic Eligibility Requirements:

 

Ø       Age 30-65

Ø       Previous hysterectomy and removal of both ovaries.

Ø       Experiencing decreased sexual desire (libido) or arousal, with difficulty achieving orgasm.

Ø       Must be sexually active at least once a month, even if the sexual activity may not be fully satisfying.

Ø       Certain medications used currently or in the past may exclude participation in this trial.

 

Testing is performed at Coastal Connecticut Research offices and is provided at no charge.  We are happy to share test results with your primary physician:

 

Ø       EKG

Ø       lab work and physical exam

 

Duration of study:

 

Ø       7 visits over 20 weeks, starting with the baseline visit when medication is first given.

 

Compensation:

 

Ø       Participants will receive $25 per visit, beginning with the baseline visit when medication is first given. On two visits subjects will be required to stay at the Coastal Connecticut Research office for 6 hours, and compensation for those visits will be $100 each. With successful completion of the study this totals $325 for 7 visits.

 

Confidentiality:

 

All information collected from patients is kept strictly private. While all study information from participating women will be made available to the sponsor of this study and to the FDA, in all but rare cases (for example, an audit or investigation) your identity will remain unknown to them and to others connected with this study. We are happy to share all test results with your primary physician.

 

Please note:

 

The preceding is an overview of this clinical trial and is intended to provide prospective patients with information that may help them decide whether to consider participating in the trial. There are additional details regarding inclusion/exclusion criteria, and details important to making a final decision regarding participation that are not listed on this page. These will be discussed with interested participants in person by a member of Coastal Connecticut Research, and all relevant information will be provided in the Informed Consent Form that must be reviewed by the prospective participant.

 

We hope that you will consider joining us at Coastal Connecticut Research in this research trial. Together we can help develop new solutions for problems faced by today’s active women.