Comparing Oral and Transdermal Estrogen Therapy

Importance of Estrogen in Female Sexual Function

Female sexual dysfunction (FSD) is often linked to decreasing estrogen levels during the menopausal transition. Studies indicate that at least 23% of naturally menopausal women experience distress due to low sexual desire. Recognizing its significance, the US Food and Drug Administration has classified FSD as a serious condition with unmet needs, emphasizing the importance of patient-oriented drug development.

Recent Research Findings

A study published in JAMA investigates the effectiveness of oral versus transdermal estrogen therapy in enhancing sexual function among early postmenopausal women. While previous research has shown that estrogen treatments, either alone or in combination with progesterone, can improve sexual function, no direct comparisons have been made regarding the routes or forms of estrogen administration.

Study Overview

The ancillary study of the Kronos Early Estrogen Prevention Study (KEEPS) aims to fill this gap. This four-year prospective, randomized, double-blinded, placebo-controlled trial involved healthy, recently menopausal women. Data collection occurred between July 2005 and June 2008, with analysis conducted from July 2010 to June 2017.

Participant Details

Out of 727 KEEPS participants, 670 women aged 42 to 58 years, within 36 months of their last menstrual period, agreed to participate. They were randomly assigned to one of three treatment groups:

1. Oral estrogens at 0.45 mg/day
2. Transdermal estrogen at 50 mcg/day
3. Placebo

Women in the first two groups also received either 200 mg of oral micronized progesterone or a placebo for 12 days each month, depending on their randomization.

Methodology for Assessing Sexual Function

Data on sexual function were collected at baseline, as well as at 18, 36, and 48 months. Participants completed the Female Sexual Function Inventory (FSFI) questionnaire, which evaluates various aspects of sexual function, including desire, arousal, lubrication, orgasm, satisfaction, and pain. FSFI scores range from 0 to 36, with higher scores indicating better sexual function. Low sexual function (LSF) was defined as an FSFI overall score below 26.55.

Study Results and Implications

Results indicate that transdermal estrogen treatment modestly improved sexual function in early postmenopausal women. However, it remains uncertain whether this treatment alleviated symptoms of distress. When comparing the two forms of estrogen therapy, the findings suggest that transdermal estrogen may be the more effective option for enhancing sexual function.

Conclusion and Reference

This research highlights the potential benefits of transdermal estrogen therapy in addressing sexual dysfunction among early postmenopausal women.

Written by Christine Gison
Reference: Hugh S. Taylor, MD; Aya Tal, PhD; Lubna Pal, MD; Fangyong Li, MPH; Dennis M. Black, MD; Eliot A. Brinton, MD; Matthew J. Budoff, MD; Marcelle I. Cedars, MD; Wei Du, MS; Howard N. Hodis, MD; Rogerio A. Lobo, MD; JoAnn E. Manson, MD, DrPH; George R. Merriam, MD; Virginia M. Miller, PhD; Frederick Naftolin, MD; Genevieve Neal-Perry, MD, PhD; Nanette F. Santoro, MD; Sherman M. Harman, MD, PhD. Effects of Oral vs Transdermal Estrogen Therapy on Sexual Function in Early Postmenopause Ancillary Study of the Kronos Early Estrogen Prevention Study (KEEPS). JAMA Internal Med, August 2017 DOI :10.1001/jamainternmed.2017.3877