IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
A Long-Term Study to Evaluate the Safety of Asoprisnil and Estrogen Administration to Postmenopausal Women
This study has been completed.
Sponsor:
Abbott
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00152295
First received: September 7, 2005
Last updated: May 27, 2008
Last verified: May 2008
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
| Postmenopause | Drug: Asoprisnil/Premarin | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Long-Term Extension Safety Study of J867 Administered With Estrogen to Postmenopausal Women |
Resource links provided by NLM:
Further study details as provided by Abbott:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 18 |
| Study Start Date: | April 2001 |
| Study Completion Date: | December 2001 |
| Primary Completion Date: | December 2001 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: Asoprisnil/Premarin
10 mg (2-5mg tablets) asoprisnil and 0.625 mg Premarin tablets, oral daily for 6 months
|
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.
Eligibility| Ages Eligible for Study: | 48 Years to 65 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00152295
Please refer to this study by its ClinicalTrials.gov identifier: NCT00152295
Sponsors and Collaborators
Abbott
Investigators
| Study Chair: | Medical Director | Abbott |
More Information
| Responsible Party: | Cynthia Mattia-Goldberg, Abbott |
| ClinicalTrials.gov Identifier: | NCT00152295 History of Changes |
| Other Study ID Numbers: |
M01-280 |
| Study First Received: | September 7, 2005 |
| Last Updated: | May 27, 2008 |
Keywords provided by Abbott:
|
Postmenopausal Amenorrhea Hormone replacement therapy |
HRT asoprisnil Estrogen Replacement Therapy, postmenopause |
Additional relevant MeSH terms:
|
Estrogens Estrogens, Conjugated (USP) Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 23, 2017