Summary:
The Replenish Trial is a clinical research study evaluating the safety and effectiveness of an investigational medication for menopausal symptoms including hot flashes and sweating. The study will measure the effectiveness of the study drug in managing the incidence of endometrial hyperplasia, a condition when the lining of the uterus becomes too thick.
Once enrolled in the study, women will complete a screening period of up to 42 days. Turing the screening period, all women will be provide with a diary to self-assess the frequency and severity of their hot flashes and sweating, as well as other symptoms. At the end of the screening period you may be asked to participate in the study treatment part of the study. The REPLENISH study includes a 12 month study treatment period. During that time, women must attend seven in-office study visits and document their experience using a provided diary.
Throughout this clinical trial, participating women will receive regular study-related general health check-ups and menopausal symptoms will be monitored on a regular basis.
All study-related visits and laboratory test are free of charge. Compensation for time, travel, and expenses may be available.
Qualified Participants Must:
• Be female
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Be between 40 and 65 years of age
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Be postmenopausal with an intact uterus
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Be in generally good health
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Be willing to participate in a clinical trial