A Long-Term Study to Evaluate the Safety of Asoprisnil and Estrogen Administration to Postmenopausal Women

A Phase II Long-Term Extension Safety Study of J867 Administered With Estrogen to Postmenopausal Women

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00152295

Enrollment

Registered

2005-09-09

Start date

2001-04-30

Completion date

2001-12-31

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

Postmenopause

Keywords

Postmenopausal, Amenorrhea, Hormone replacement therapy, HRT, asoprisnil, Estrogen Replacement Therapy, postmenopause

Brief summary

The objective of this study is to determine the long-term safety of asoprisnil 10 mg when administered to postmenopausal women with Premarin® 0.625 mg

Detailed description

The objective of this study is to determine the long-term safety of asoprisnil 10 mg (2-5mg tablets) when taken with Premarin® 0.625 mg, by postmenopausal women, for 6 months after an initial 12 weeks in Study M00-198. Pharmacodynamic effects to be assessed include uterine 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

10 mg (2-5mg tablets) asoprisnil and 0.625 mg Premarin tablets, oral daily for 6 months

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

48 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Successful completion of study M00-198 * Continued good general health * Negative urine pregnancy test

Exclusion criteria

* History of known or suspected cancer other than basal cell carcinoma in last 5 years * History of reproductive endocrine disorder * Submucous or other symptomatic fibroid which would confound efficacy * Ovarian mass * Ongoing treatment with an excluded medication * Stenosis of the cervix * Any abnormal lab result the study-doctor considers significant.

Design outcomes

Primary

Measure	Time frame
The percent of subjects in each endometrial biopsy diagnostic category summarized using SPRM Classification System.	Throughout Study
The percentage of subjects in each endometrial biopsy diagnostic category summarized using SPRM Classification System	Months 3,6
Change from baseline in endometrial thickness (mm) as measured by transvaginal ultrasound.	Months 3,6

Secondary

Measure	Time frame
Frequency and amount of vaginal bleeding assessed via daily diary.	Throughout study
Global efficacy question	Month 6
Frequency and severity of hot flushes assessed via daily diary.	Throughout study
Mean change from baseline in endocrine determinations.	Months 2,4,and 6

Outcome results

None listed

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