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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00152282

Enrollment

105

Registered

2005-09-09

Start date

2000-09-30

Completion date

2001-08-31

Last updated

2008-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amenorrhea, Postmenopause

Keywords

Postmenopausal, Amenorrhea, Hormone replacement therapy, HRT, asoprisnil

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

Interventions

DRUGAsoprisnil/Premarin

Asoprisnil 5mg and Premarin 0.625 mg Tablets, oral Daily for 12 weeks

DRUGPlacebo and Premarin

Placebo and Premarin 0.625 mg Tablets, oral Daily for 12 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

48 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Assessment of endometrium by endometrial biopsy	Week 12
Change from baseline in endometrial thickness as assessed by ultrasound	Week 12

Secondary

Measure	Time frame
Frequency and amount of vaginal bleeding via patient diary.	Week 4, 8, and 12
Incidence of hot flushes	Week 4, 8, and 12
Presence or absence of endometrial hyperplasia.	Week 12
Response to global efficacy question regarding improvement in menopause symptoms.	Week 12

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026