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Completed

NCT Number: NCT00152295

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

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

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Key information

Conditions

Postmenopause Amenorrhea Menstruation Disturbances Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

48 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Asoprisnil/Premarin

Drug

10 mg (2-5mg tablets) asoprisnil and 0.625 mg Premarin tablets, oral daily for 6 months

Primary outcomes

  1. The percent of subjects in each endometrial biopsy diagnostic category summarized using SPRM Classification System.

    Time frame: Throughout Study

  2. The percentage of subjects in each endometrial biopsy diagnostic category summarized using SPRM Classification System

    Time frame: Months 3,6

  3. Change from baseline in endometrial thickness (mm) as measured by transvaginal ultrasound.

    Time frame: Months 3,6

Secondary outcomes

  1. Frequency and amount of vaginal bleeding assessed via daily diary.

    Time frame: Throughout study

  2. Frequency and severity of hot flushes assessed via daily diary.

    Time frame: Throughout study

  3. Mean change from baseline in endocrine determinations.

    Time frame: Months 2,4,and 6

  4. Global efficacy question

    Time frame: Month 6

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study title

A Phase II Long-Term Extension Safety Study of J867 Administered With Estrogen to Postmenopausal Women

Important dates

Study start
2001
Primary completion
2001
Study completion
2001
First posted
Sep 9, 2005
Registry last updated
May 29, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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