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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00152295
First Posted: September 9, 2005
Last Update Posted: May 29, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Abbott
  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: None (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

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

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


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
First Submitted: September 7, 2005
First Posted: September 9, 2005
Last Update Posted: May 29, 2008
Last Verified: May 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