Clinical trial NCT00152282: A Study to Evaluate the Safety and Effectiveness of Asoprisnil and Estrogen Administration to Postmenopausal Women
Official title: A Phase II Pilot Study to Evaluate the Safety and Efficacy of J867 Administered With Estrogen to Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Amenorrhea
Postmenopause
Keywords: Postmenopausal
Amenorrhea
Hormone replacement therapy
HRT
asoprisnil
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2005-09-09
Enrollment: 105
Sex: FEMALE
Minimum age (years): 48
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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

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

Primary outcomes:
measure: Assessment of endometrium by endometrial biopsy
timeFrame: Week 12
measure: Change from baseline in endometrial thickness as assessed by ultrasound
timeFrame: Week 12
Secondary outcomes:
measure: Frequency and amount of vaginal bleeding via patient diary.
timeFrame: Week 4, 8, and 12
measure: Incidence of hot flushes
timeFrame: Week 4, 8, and 12
measure: Presence or absence of endometrial hyperplasia.
timeFrame: Week 12
measure: Response to global efficacy question regarding improvement in menopause symptoms.
timeFrame: Week 12
Other outcomes:
Locations:
Study officials:
affiliation: Abbott
name: Medical Director
role: STUDY_CHAIR
References: