NCT00152295

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2001

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2001

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2001

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 9, 2005

Completed
Last Updated

May 29, 2008

Status Verified

May 1, 2008

Enrollment Period

8 months

First QC Date

September 7, 2005

Last Update Submit

May 27, 2008

Conditions

Postmenopause

Keywords

PostmenopausalAmenorrheaHormone replacement therapyHRTasoprisnilEstrogen Replacement Therapy, postmenopause

Outcome Measures

Primary Outcomes (3)

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

    Throughout Study

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

    Months 3,6

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

    Months 3,6

Secondary Outcomes (4)

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

    Throughout study

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

    Throughout study

  • Mean change from baseline in endocrine determinations.

    Months 2,4,and 6

  • Global efficacy question

    Month 6

Study Arms (1)

1

EXPERIMENTAL
Drug: Asoprisnil/Premarin

Interventions

Asoprisnil/PremarinDRUG

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

1

Eligibility Criteria

Age48 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Successful completion of study M00-198
  • Continued good general health
  • Negative urine pregnancy test

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Amenorrhea

Interventions

asoprisnilEstrogens, Conjugated (USP)

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Estradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Medical Director

    Abbott

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 9, 2005

Study Start

April 1, 2001

Primary Completion

December 1, 2001

Study Completion

December 1, 2001

Last Updated

May 29, 2008

Record last verified: 2008-05