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

Postmenopause Clinical Trial

Official title:

A Phase II Pilot Study to Evaluate the Safety and Efficacy of J867 Administered With Estrogen to Postmenopausal Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00152282
• Other study ID #: M00-198
• Status: Completed
• Phase: Phase 2
• First received: September 7, 2005
• Last updated: May 27, 2008
• Start date: September 2000
• Est. completion date: August 2001

Study information

• Verified date: May 2008
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: August 2001
• Est. primary completion date: August 2001
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 48 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Amenorrhea
• Postmenopause

Intervention

Drug:
• Asoprisnil/Premarin
Asoprisnil 5mg and Premarin 0.625 mg Tablets, oral Daily for 12 weeks
• Asoprisnil/Premarin
Asoprisnil 10mg and Premarin 0.625 mg Tablets, oral Daily for 12 weeks
• Asoprisnil/Premarin
Asoprisnil 25mg and Premarin 0.625 mg Tablets, oral Daily for 12 weeks
• Placebo and Premarin
Placebo and Premarin 0.625 mg Tablets, oral Daily for 12 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of endometrium by endometrial biopsy		Week 12	Yes
Primary	Change from baseline in endometrial thickness as assessed by ultrasound		Week 12	No
Secondary	Frequency and amount of vaginal bleeding via patient diary.		Week 4, 8, and 12	No
Secondary	Incidence of hot flushes		Week 4, 8, and 12	No
Secondary	Presence or absence of endometrial hyperplasia.		Week 12	Yes
Secondary	Response to global efficacy question regarding improvement in menopause symptoms.		Week 12	No