A Study to Evaluate the Safety and Effectiveness of Asoprisnil and Estrogen Administration to Postmenopausal Women
Amenorrhea, Postmenopause
About this trial
This is an interventional treatment trial for Amenorrhea focused on measuring Postmenopausal, Amenorrhea, Hormone replacement therapy, HRT, asoprisnil
Eligibility Criteria
Inclusion Criteria: Postmenopausal women with an intact uterus Body mass index (BMI) between 18.0 - 33.0 Good general health Endometrial thickness ≤ 4 mm by TVU No history or suspected endometrial hyperplasia Negative urine pregnancy test Pap smear in last 6 months with no evidence of malignancy or pre-malignant changes Mammogram without suspicion of malignancy within last 6 months Endometrial biopsy with no evidence of pathologic changes within last 6 months Exclusion Criteria: Any abnormal lab result the study-doctor considers significant History of severe reaction to hormone therapy Receiving hormone therapy Currently using phytoestrogenic compounds, such as red clover, black cohosh (Promensil and Remifemin), dong quai, ginseng and soy isoflavones History or known or suspected cancer other than basal cell carcinoma Stenosis of the cervix History of reproductive endocrine disorder Washout requirement for hormonal therapy not met Ovarian mass Submucus or other symptomatic fibroid which would confound efficacy
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Placebo Comparator
1
2
3
4