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Transdermal Hormones Better than Oral for Improving Women's Sexual Quality of Life: Presented at ACOG

By Bruce Sylvester

NEW ORLEANS, LA -- May 2, 2003 -- Transdermal CombiPatch (estradiol/norethindrone) appears to improve the quality of life of postmenopausal women to a greater extent than does oral Prempro (conjugated equine estrogen/medroxyprogesterone), according to a comparative randomised trial.

Researchers reported these findings here on April 30^th at the 51^st Annual Meeting of the American College of Obstetricians and Gynecologists. For their evaluation they used comparative cumulative scoring of the sexual and psychosocial areas on the Menopause-Specific Quality-of-Life Questionnaire (MENQOL).

"Transdermal therapy enters the body through the skin, and oral agents metabolize through the liver. This appears to have an effect on drug efficacy," said investigator and presenter James Simon, MD, clinical professor of obstetrics and gynecology, George Washington University School of Medicine, Washington, DC. "We saw results of this difference in the outcomes of this head-to-head study."

"These results are not only about two alternative hormone treatments, they are about delivery systems and how they might affect drug efficacy in certain instances," he explained.

The trial was a randomised, double-blind, double-dummy, parallel group treatment-group, multi-center trial. The investigators enrolled 186 women between 1 and 6 years post-menopause.

Following a 4-week placebo run-in phase, the investigators randomised subjects to 20 weeks of treatment with either transdermal CombiPatch 50 mg E2/140mg norethindrone) plus placebo capsule or Prempro capsule (0.625 mg conjugated equine estrogen/2.5 mg methoxyprogesterone acetate) plus placebo patch.

Researchers interviewed the subjects by phone using the MEMQOL every 4 weeks beginning at Week 0. The subjects gave self-rated responses of 0 to 6 (0=not bothered at all, 6= extremely bothered) on three quality-of-life parameters, including change in sexual desire, vaginal dryness during intercourse and avoiding intimacy.

At end point (20 weeks), 33% of 81 women on CombiPatch reported improvement in Quality of Life scores compared to 17% of 84 on Prempro. Fewer CombiPatch subjects reported declined sexual function during the trial than Prempro subjects (2.5% vs. 4.8%, overall P=0.045, sexual domain P=0.0075, psychosocial domain P=0.0094).

The investigators concluded that transdermal patch hormone therapy appears to be a more efficacious choice than oral therapy for postmenopausal women with reduced libido.

The study received support from Novartis Pharmaceuticals Corporation.


[Study title: CombiPatch ® Significantly Improves Women's Sexual Quality of Life Compared to Prempro ™ in Randomized Trial. Poster: 1.]

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