Preventing Sexual Dysfunction in Women on Aromatase Inhibitors
If you agree to take part in this study, you will be randomly assigned (as in a roll of
dice) to 1 of 2 study groups. You will have a 1 in 3 chance of being assigned to Group 1
and a 2 out of 3 chance of being assigned to Group 2.
All women enrolled in this study:
- You will complete a set of 8 or 9 brief questionnaires at the start of the study and 6
and 12 months afterwards. The questionnaires should take about 45 to 50 minutes to
fill out each time. The questionnaires will be mailed to you with a postage paid return
envelope. They include questions about your background and medical history, any
symptoms that you may have while taking AIs such as hot flashes, muscle pain, and
stiffness. There are also questions about how much exercise you are getting, sexual
function and satisfaction, your satisfaction with the treatment you are receiving as
part of this study, and if you are continuing to take your AI medication and how often
you are taking it. If the study staff does not receive your questionnaires within 2
weeks of mailing them, you will receive reminder phone calls once a week for up to 3
weeks unless you tell the study staff that you are leaving the study. If you do not
contact the study staff or you do not mail in your questionnaires after 6 weeks, you
will no longer be a part of the study.
- Along with your questionnaires, you will also be mailed a kit approved by the Food and
Drug Administration (FDA) to test your vaginal pH at home and will be provided a
postage paid return envelope to mail it back to the study doctor. The kit includes a
small plastic stick that you put into your vagina for a moment to test your vaginal
fluid. The end of the stick turns different colors, depending on the pH in your
vagina. The vagina becomes less acidic after menopause, which may increase the risk of
vaginal infections. Sometimes vaginal moisturizers can correct this problem by
restoring a pH similar to what it was before menopause.
- You will also receive a detailed written handout about ways to keep your bones stronger
during treatment with AIs and ways to prevent AI side effects such as muscle aches,
stiffness, sexual problems, and hot flashes.
Group 2 women only:
- You will be given a password to use an interactive, internet-based website called
Tendrils: Sexual Renewal after Cancer before, during and after treatment with AIs. You
will also be given a printed guide for the website with a timeline for when you should
read certain sections and suggestions for trying some of the "exercises" to improve
sexual communication, increase affection, and prevent vaginal dryness.
- A counselor will also schedule times to call you for up to 30 minutes during Weeks 2,
4, 6, 8, 10, 12, 16, 20, and 24 of the study to ask how you are doing, if you have been
able to avoid side effects from the AIs, and if you need any help using the information
in your handout or the website. About 1 of 5 counseling phone calls will be
audio-recorded so that researchers can make sure the counselor is covering the topics
scheduled for each session. These recordings will usually only be heard by the
counselor, the Study Chair, and another MD Anderson faculty member (Andrea Bradford,
PhD) who will help with supervising and rating the counselor. Once a tape has been
rated (usually within one month of the counseling session), it will be erased. The tape
may also be reviewed by other health authorities or the IRB of MD Anderson to check
that the research is being done safely and correctly. If either of these 2 groups
review the tapes, the will be destroyed right after they are reviewed. Tapes will only
be labelled by your study number, but the counselor may call you by name during the
session. All information will be held in strict confidentiality by research staff.
- You will be randomly assigned (as in the toss of a coin) to get a 6-month supply of 1
of 2 vaginal moisturizers (Luvena or Hyalo-Gyn) to use 2 or 3 times a week.
Researchers want to know if one works better than the other for women on AIs.
- You will be given a 6-month supply of a water-based vaginal lubricant to use during
- You will also be given a vaginal dilator, which is used to help women to relax their
pelvic floor muscles and to increase blood flow into the vaginal walls.
- All of the materials that you need for the study, including handouts, instructions on
using the web site, instructions on using the vaginal moisturizer, vaginal lubricant,
and vaginal dilator, as well as the supply of those products, will be mailed to you in
a study kit as soon as you complete your baseline questionnaires.
Length of Study Your active study participation will be over after you complete the
questionnaires at 12 months.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Sexual Dysfunction Rate Reduction
The primary outcome measure will be the total score from the Female Sexual Function Index (FSFI), which is calculated according to a standard scoring algorithm and has a well-validated cut-off score of 26.55 or below indicating sexual dysfunction. FSFI subscale scores will also be calculated and analyzed.
Leslie R. Schover, PHD
UT MD Anderson Cancer Center
United States: Institutional Review Board
|UT MD Andreson Cancer Center||Houston, Texas 77030|