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

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 Endpoint Classification: Safety Study 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

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 ] [ Designated as safety issue: Yes ]
The percentage of subjects in each endometrial biopsy diagnostic category summarized using SPRM Classification System [ Time Frame: Months 3,6 ] [ Designated as safety issue: Yes ]
Change from baseline in endometrial thickness (mm) as measured by transvaginal ultrasound. [ Time Frame: Months 3,6 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Frequency and amount of vaginal bleeding assessed via daily diary. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Frequency and severity of hot flushes assessed via daily diary. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Mean change from baseline in endocrine determinations. [ Time Frame: Months 2,4,and 6 ] [ Designated as safety issue: No ]
Global efficacy question [ Time Frame: Month 6 ] [ Designated as safety issue: No ]


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
Genders 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

Sponsors and Collaborators

Abbott

Investigators


Study Chair:	Medical Director	Abbott

More Information

No publications provided


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
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abbott:


Postmenopausal Amenorrhea Hormone replacement therapy	HRT asoprisnil Estrogen Replacement Therapy, postmenopause

ClinicalTrials.gov processed this record on March 01, 2015