A Long-Term Study to Evaluate the Safety of Asoprisnil and Estrogen Administration to Postmenopausal Women
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ClinicalTrials.gov Identifier: NCT00152295 |
Recruitment Status :
Completed
First Posted : September 9, 2005
Last Update Posted : May 29, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Postmenopause | Drug: Asoprisnil/Premarin | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 18 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase II Long-Term Extension Safety Study of J867 Administered With Estrogen to Postmenopausal Women |
Study Start Date : | April 2001 |
Actual Primary Completion Date : | December 2001 |
Actual Study Completion Date : | December 2001 |

Arm | Intervention/treatment |
---|---|
Experimental: 1 |
Drug: Asoprisnil/Premarin
10 mg (2-5mg tablets) asoprisnil and 0.625 mg Premarin tablets, oral daily for 6 months |
- The percent of subjects in each endometrial biopsy diagnostic category summarized using SPRM Classification System. [ Time Frame: Throughout Study ]
- The percentage of subjects in each endometrial biopsy diagnostic category summarized using SPRM Classification System [ Time Frame: Months 3,6 ]
- Change from baseline in endometrial thickness (mm) as measured by transvaginal ultrasound. [ Time Frame: Months 3,6 ]
- Frequency and amount of vaginal bleeding assessed via daily diary. [ Time Frame: Throughout study ]
- Frequency and severity of hot flushes assessed via daily diary. [ Time Frame: Throughout study ]
- Mean change from baseline in endocrine determinations. [ Time Frame: Months 2,4,and 6 ]
- Global efficacy question [ Time Frame: Month 6 ]

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Ages Eligible for Study: | 48 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00152295
Study Chair: | Medical Director | Abbott |
Responsible Party: | Cynthia Mattia-Goldberg, Abbott |
ClinicalTrials.gov Identifier: | NCT00152295 |
Other Study ID Numbers: |
M01-280 |
First Posted: | September 9, 2005 Key Record Dates |
Last Update Posted: | May 29, 2008 |
Last Verified: | May 2008 |
Postmenopausal Amenorrhea Hormone replacement therapy |
HRT asoprisnil Estrogen Replacement Therapy, postmenopause |
Estrogens, Conjugated (USP) Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |