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Published on: May 23, 2014
Endometrial effects of a single early luteal dose of the selective progesterone receptor modulator CDB-2914
Pamela Stratton1, Eric D Levens, Beth Hartog
1Program in Reproductive and Adult Endocrinology, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD 20892-1109, USA.
Objective:
To test potential contraceptive mechanisms of the selective P receptor modulator CDB-2914 in the early luteal phase.
Design:
Prospective randomized clinical trial.
Setting:
Clinical research center.
Patient(S):
Fifty-six women with regular cycles.
Intervention(S):
Women received a single dose of CDB-2914 (10, 50, or 100 mg) or placebo given after ovulation and within 2 days of the LH surge. Four to 6 days later, a transvaginal ultrasound scan measured endometrial thickness, and an endometrial biopsy specimen was obtained.
Main Outcome Measure(S):
The endometrium was evaluated by thickness and by immunohistochemical analysis for P-dependent markers; safety laboratory tests were performed, and E(2) and P levels were obtained.
Result(S):
CDB-2914 caused a significant dose-dependent decrease in endometrial thickness, an increase in glandular P receptors, and a decrease in peripheral node addressins. Estradiol and P levels and menstrual cycle timing were not altered. No adverse effects were observed.
Conclusion(S):
The alteration in endometrial thickness and P-dependent markers of implantation in the absence of changes in hormone levels and cycle length suggests that CDB-2914 may have contraceptive properties.
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