A Study to Evaluate the Safety and Effectiveness of Asoprisnil and Estrogen Administration to Postmenopausal Women - Full Text View

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00152282

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 II

Drug Information available for: Estrogens, conjugated Asoprisnil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase II Pilot Study to Evaluate the Safety and Efficacy of J867 Administered With Estrogen to Postmenopausal Women

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
1: Experimental	Drug: Asoprisnil/Premarin Asoprisnil 5mg and Premarin 0.625 mg Tablets, oral Daily for 12 weeks
2: Experimental	Drug: Asoprisnil/Premarin Asoprisnil 10mg and Premarin 0.625 mg Tablets, oral Daily for 12 weeks
3: Experimental	Drug: Asoprisnil/Premarin Asoprisnil 25mg and Premarin 0.625 mg Tablets, oral Daily for 12 weeks
4: Placebo Comparator	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

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

Keywords provided by Abbott:

Postmenopausal
Amenorrhea
Hormone replacement therapy
HRT
asoprisnil

Study placed in the following topic categories:

Estrogens, Conjugated (USP)
Menstruation Disturbances
Amenorrhea

Additional relevant MeSH terms:

Estrogens
Pathologic Processes
Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009