Preventing Sexual Dysfunction With Aromatase Inhibitors

PHASE2CompletedINTERVENTIONAL
Enrollment

187

Participants

Timeline

Start Date

December 5, 2012

Primary Completion Date

August 11, 2017

Study Completion Date

August 11, 2017

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.

Trial Locations (1)

77030

University of Texas MD Anderson Cancer Center, Houston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Fidia Farmaceutici s.p.a.

INDUSTRY

collaborator

Laclede, Inc.

INDUSTRY

collaborator

Duncan Family Institute Seed Money Grant

UNKNOWN

lead

M.D. Anderson Cancer Center

OTHER