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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00152282
First received: September 7, 2005
Last updated: May 27, 2008
Last verified: May 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Amenorrhea
Postmenopause
 Drug: Asoprisnil/Premarin
Drug: Placebo and Premarin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II Pilot Study to Evaluate the Safety and Efficacy of J867 Administered With Estrogen to Postmenopausal Women

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:
  • Assessment of endometrium by endometrial biopsy [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
  • Change from baseline in endometrial thickness as assessed by ultrasound [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency and amount of vaginal bleeding via patient diary. [ Time Frame: Week 4, 8, and 12 ] [ Designated as safety issue: No ]
  • Incidence of hot flushes [ Time Frame: Week 4, 8, and 12 ] [ Designated as safety issue: No ]
  • Presence or absence of endometrial hyperplasia. [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
  • Response to global efficacy question regarding improvement in menopause symptoms. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Enrollment: 105
Study Start Date: September 2000
Study Completion Date: August 2001
Primary Completion Date: August 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Asoprisnil/Premarin
Asoprisnil 5mg and Premarin 0.625 mg Tablets, oral Daily for 12 weeks
Experimental: 2 Drug: Asoprisnil/Premarin
Asoprisnil 10mg and Premarin 0.625 mg Tablets, oral Daily for 12 weeks
Experimental: 3 Drug: Asoprisnil/Premarin
Asoprisnil 25mg and Premarin 0.625 mg Tablets, oral Daily for 12 weeks
Placebo Comparator: 4 Drug: Placebo and Premarin
Placebo and Premarin 0.625 mg Tablets, oral Daily for 12 weeks

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

  Eligibility

Ages Eligible for Study:   48 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00152282

Sponsors and Collaborators
Abbott
Investigators
Study Chair: Medical Director Abbott
  More Information

No publications provided

Responsible Party: Cynthia Mattia-Goldberg, Abbott
ClinicalTrials.gov Identifier: NCT00152282     History of Changes
Other Study ID Numbers: M00-198
Study First Received: September 7, 2005
Last Updated: May 27, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
Postmenopausal
Amenorrhea
Hormone replacement therapy
HRT
asoprisnil

Additional relevant MeSH terms:
Amenorrhea
Menstruation Disturbances
Pathologic Processes
Estrogens, Conjugated (USP)
Estrogens
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013