Preventing Sexual Dysfunction With Aromatase Inhibitors

Summary

Aromatase inhibitors (AIs) are used to try to stop breast cancer from forming or returning after treatment in women who are in menopause and who had breast cancer that was sensitive to the hormone estrogen.

The goal of this study is to learn if it is possible to prevent some AI side effects, particularly problems with vaginal dryness and pain during sexual activity. Researchers also want to compare 2 new vaginal moisturizers to see if using them regularly helps women avoid vaginal dryness. Researchers want to see if preventing these side effects will decrease the number of women who stop taking AIs due to the side effects they cause.

Conditions

• Breast Cancer

Interventions

BEHAVIORAL

Questionnaires

Completion of 8 or 9 brief questionnaires at start of study and 6 and 12 months afterwards. Questionnaires should take about 45 to 50 minutes to fill out each time.

OTHER

Education Materials

Participants receive written handout about ways to keep bones stronger during treatment with Aromatase Inhibitors (AIs) and ways to prevent AI side effects such as muscle aches, stiffness, sexual problems, and hot flashes.

OTHER

Luvena

Use vaginally 2 or 3 times a week.

OTHER

Hyalo-Gyn

Use vaginally 2 - 3 times a week.

OTHER

Vaginal Lubricant

Water-based vaginal lubricant used during sexual activity.

BEHAVIORAL

Interactive Internet-Based Website

Participants use an interactive, internet-based website called Tendrils: Sexual Renewal after Cancer before, during and after treatment with AIs.

BEHAVIORAL

Telephone Counseling.

Telephone counseling for up to 30 minutes in weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. The counselor will follow a manualized program and some sessions will be recorded.

Sponsors & Collaborators

• Fidia Farmaceutici s.p.a.

  collaborator INDUSTRY

• Laclede, Inc.

  collaborator INDUSTRY

• Duncan Family Institute Seed Money Grant

  collaborator UNKNOWN

• M.D. Anderson Cancer Center

  lead OTHER

Principal Investigators

• Abenaa M. Brewster, MD, MHS, BS · M.D. Anderson Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-12-05

Primary Completion

2017-08-11

Completion

2017-08-11

Countries

• United States

Study Locations