A Study to Evaluate the Safety and Effectiveness of Three Asoprisnil Doses in the Treatment of Women With Endometriosis

NCT00160446 | Completed Phase 2

• 1 other identifier: M99-110
• Study Type: interventional
• Target: 130
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this study is to determine the safety and effectiveness of three doses of asoprisnil, compared to placebo, in the treatment of women with endometriosis.

Conditions

Endometriosis

Keywords

Pelvic pain; Dysmenorrhea; Dyspareunia; Infertility; Asoprisnil

Outcome Measures

Primary Outcomes (1)

• Pain (dysmenorrhea, dyspareunia, pelvic pain) measured by daily diary

  Mean change from baseline to Months 1, 2, 3

Secondary Outcomes (2)

• Global efficacy question

  Final visit

• Pain (dysmenorrhea, dyspareunia, pelvic pain) pelvic tenderness and induration evaluated during office visits using modified Biberoglu and Behrman grading scale

  Each monthly visit

Study Arms (4)

1

EXPERIMENTAL

Drug: Asoprisnil

2

EXPERIMENTAL

Drug: Asoprisnil

3

EXPERIMENTAL

Drug: Asoprisnil

4

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Asoprisnil DRUG

5mg Tablet, oral Daily for 12 weeks

1

Placebo DRUG

Tablet, oral Daily for 12 weeks

4

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Surgically confirmed endometriosis
• History of menstrual cycles between 26 and 32 days
• Otherwise in good health
• Age 18-40 years, inclusive
• Subject had pain graded at Screening and Day 1 according to a scale suggested by Biberoglu and Berhman5 in at least one of the following categories:
• moderate or severe pelvic pain not related to menstruation, OR
• moderate or severe dysmenorrhea, OR
• moderate or severe pelvic tenderness elicited on pelvic examination accompanied by non-menstrual pelvic pain.
• Subject agrees to double barrier method of contraception

You may not qualify if:

• Any abnormal lab or procedure result the study-doctor considers important
• History of undiagnosed uterine bleeding or gynecological disorder
• Severe reaction(s) to hormone therapy
• History of osteoporosis or other metabolic bone disease
• Subject currently breast feeding

Sponsors & Collaborators

• Abbott: lead

MeSH Terms

Conditions

Endometriosis; Pelvic Pain; Dysmenorrhea; Dyspareunia; Infertility

Interventions

asoprisnil

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances; Pathologic Processes; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Medical Director

  Abbott

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: May 1, 2000
• Primary Completion: July 1, 2001
• Study Completion: July 1, 2001
• Last Updated: May 29, 2008

Record last verified: 2008-05