A Study to Evaluate the Safety and Effectiveness of Asoprisnil and Estrogen Administration to Postmenopausal Women

Condition(s) targeted: Amenorrhea; Postmenopause

Intervention: Asoprisnil/Premarin (Drug); Asoprisnil/Premarin (Drug); Asoprisnil/Premarin (Drug); Placebo and Premarin (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Abbott

Official(s) and/or principal investigator(s):
Medical Director, Study Chair, Affiliation: Abbott

The objective of this study is to determine the safety and effectiveness of 3 asoprisnil doses when administered to postmenopausal women with Premarin® 0. 625 mg.

Official title: A Phase II Pilot Study to Evaluate the Safety and Efficacy of J867 Administered With Estrogen to Postmenopausal Women

Study design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Assessment of endometrium by endometrial biopsy

Change from baseline in endometrial thickness as assessed by ultrasound

Secondary outcome:

Frequency and amount of vaginal bleeding via patient diary.

Incidence of hot flushes

Presence or absence of endometrial hyperplasia.

Response to global efficacy question regarding improvement in menopause symptoms.

Detailed description: The objective of this study is to determine the safety and effectiveness of asoprisnil 5, 10, and 25 mg, compared to placebo, when administered to postmenopausal women, with Premarin® 0. 625 mg, for 12 weeks. Pharmacodynamic effects to be assessed include bleeding pattern, endometrial biopsy results, and endometrial thickness. Safety assessments will include clinical laboratory results, physical examination with vital signs, pelvic and breast examinations, ultrasound results, and adverse events

Minimum age: 48 Years. Maximum age: 65 Years. Gender(s): Female.

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

Starting date: September 2000
Ending date: August 2001
Last updated: May 27, 2008