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

May 27, 2008 updated by: Abbott

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

48 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Asoprisnil/Premarin
Asoprisnil 5mg and Premarin 0.625 mg Tablets, oral Daily for 12 weeks
Drug: Asoprisnil/Premarin
Asoprisnil 10mg and Premarin 0.625 mg Tablets, oral Daily for 12 weeks
Drug: Asoprisnil/Premarin
Asoprisnil 25mg and Premarin 0.625 mg Tablets, oral Daily for 12 weeks
Experimental: 2
Drug: Asoprisnil/Premarin
Asoprisnil 5mg and Premarin 0.625 mg Tablets, oral Daily for 12 weeks
Drug: Asoprisnil/Premarin
Asoprisnil 10mg and Premarin 0.625 mg Tablets, oral Daily for 12 weeks
Drug: Asoprisnil/Premarin
Asoprisnil 25mg and Premarin 0.625 mg Tablets, oral Daily for 12 weeks
Experimental: 3
Drug: Asoprisnil/Premarin
Asoprisnil 5mg and Premarin 0.625 mg Tablets, oral Daily for 12 weeks
Drug: Asoprisnil/Premarin
Asoprisnil 10mg and Premarin 0.625 mg Tablets, oral Daily for 12 weeks
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment of endometrium by endometrial biopsy
Time Frame: Week 12
Week 12
Change from baseline in endometrial thickness as assessed by ultrasound
Time Frame: Week 12
Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Frequency and amount of vaginal bleeding via patient diary.
Time Frame: Week 4, 8, and 12
Week 4, 8, and 12
Incidence of hot flushes
Time Frame: Week 4, 8, and 12
Week 4, 8, and 12
Presence or absence of endometrial hyperplasia.
Time Frame: Week 12
Week 12
Response to global efficacy question regarding improvement in menopause symptoms.
Time Frame: Week 12
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2000

Primary Completion (Actual)

August 1, 2001

Study Completion (Actual)

August 1, 2001

Study Registration Dates

First Submitted

September 7, 2005

First Submitted That Met QC Criteria

September 7, 2005

First Posted (Estimate)

September 9, 2005

Study Record Updates

Last Update Posted (Estimate)

May 29, 2008

Last Update Submitted That Met QC Criteria

May 27, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M00-198

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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