A DOSE-FINDING, CROSS-OVER STUDY TO EVALUATE THE EFFECT OF A TRANSDERMAL NESTORONE®-ESTRADIOL GEL ON OVULATION SUPPRESSION IN YOUNG WOMEN
ESC Congress Library. Sitruk-Ware R. May 28, 2014; 50604; A-189 Disclosure(s): I am an employee of the Population Council, a not-for-profit organization. the project was supported by Population Council funds and the material provided by Antares Pharma. I personally received no specific grants for this study
Dr. Regine L. Sitruk-Ware
Dr. Regine L. Sitruk-Ware
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Abstract
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Objective: To determine the lowest effective dose of Nestorone/Estradiol (NES/E2) transdermal gel delivery to suppress ovulation in healthy premenopausal women.
Study Design: This was a phase II, dose finding, randomized, triple cross-over study to evaluate the effect of NES/E2 transdermal gel delivery in 3 different doses in 18 volunteers.
Materials and Methods: Each woman received the 3 doses of the NES/E2 gel in random order, either high (4.5 mg NES/1.5 mg E2), medium (3.0 mg NES/1.0 mg E2) and low (1.5 mg NES/0.5 mg E2). Ten per cent of the steroid doses are absorbed after transdermal application. The gel was applied daily to a measured area of the abdomen for 21 consecutive days. Ovulation was confirmed in a baseline cycle. Between each treatment, recovery of ovulation was documented in a wash-out cycle before the next dose was tested. This was measured by transvaginal ultrasound and Progesterone serum levels. Estradiol measured assessed residual endogenous levels and exogenous therapy. SHBG was measured before and after each treatment.
Results: All doses of NES/E2 gel showed ovulation suppression in women who used the gel. The lower dose, although able to suppress ovulation, did not completely suppress follicle growth, as reflected by larger follicles and high levels of serum E2. The high dose gel led to levels of both hormones above target levels. The medium dose of the gel showed less intra individual variations for both steroids and led to stable levels of E2 within a mid-follicular range. A small percentage of large follicles indicated good ovarian suppression. There was minimal breakthrough bleeding during 3 weeks of use and no major differences between doses. No change in SHBG was observed with either dose
Conclusion: The concept of a transdermal contraceptive using Nestorone, a progestin close to progesterone, and natural estrogen (Estradiol) showed promising results and may represent a safe and effective novel hormonal method of contraception. Additional studies are required to establish safety and efficacy in a larger population of women.
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