A Study to Evaluate the Effects of Asoprisnil(J867) in Women With Uterine Fibroids Who Are Scheduled for a Hysterectomy

NCT00150644 | Completed Phase 2

• 1 other identifier: C02-003
• Study Type: interventional
• Target: 33
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this study is to evaluate the effects of 10 mg and 25 mg doses of asoprisnil, compared to placebo, taken daily for 12 weeks, on uterine blood flow and the morphology of the endometrium and uterine fibroids.

Conditions

Uterine Fibroids; Leiomyoma

Keywords

Fibroid Uterus; Leiomyoma; Uterine Fibroids; Hysterectomy; Asoprisnil

Outcome Measures

Primary Outcomes (1)

• Change from baseline to the Final Visit in uterine artery blood flow as determined by change in Resistance Index.

  Final visit

Secondary Outcomes (8)

• Change from baseline in uterine artery blood flow as determined by change in Pulsatility Index.

  Final Visit

• Morphological changes in the endometrium, myometrium and uterine fibroids.

  Final Visit

• Change from baseline in menstrual pictogram score.

  Final Month

• Percent change from baseline in volume of the largest fibroid.

  Final Visit

• Endometrial thickness (post-treatment histologic evaluation).

  Final Visit

Study Arms (3)

1

EXPERIMENTAL

Drug: Asoprisnil

2

EXPERIMENTAL

Drug: Asoprisnil

3

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Asoprisnil DRUG

Asoprisnil 10mg Tablet, oral Daily for 12 weeks

Also known as: J867

1

Placebo DRUG

Placebo Tablet, oral Daily for 12 weeks

3

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Premenopausal women, at least 18 years of age
• Diagnosis of uterine fibroid(s), confirmed by ultrasound
• History of menstrual cycles between 17 and 42 days
• Otherwise in good health
• Scheduled for a hysterectomy at the end of the treatment period
• Negative pregnancy test
• Agrees to double barrier method of contraception
• Pap test with no evidence of malignancy or pre-malignant changes
• Endometrial biopsy with no significant histological disorder

You may not qualify if:

• Less than 3 months after having a baby or breast-feeding
• Any abnormal lab or procedure result the study-doctor considers important
• Severe reaction(s) to or are currently using any hormone therapy
• History of cancer or alcohol or drug abuse
• Diagnosis of Polycystic Ovary Syndrome
• History of prolactinoma
• Current use of Intrauterine Device
• Significant gynecological disorder
• Uterine size \> 32 weeks gestation
• Current diagnosis of endometriosis
• Uterine artery embolization within 6 months

Sponsors & Collaborators

• Abbott: lead

Related Publications (1)

• Williams AR, Critchley HO, Osei J, Ingamells S, Cameron IT, Han C, Chwalisz K. The effects of the selective progesterone receptor modulator asoprisnil on the morphology of uterine tissues after 3 months treatment in patients with symptomatic uterine leiomyomata. Hum Reprod. 2007 Jun;22(6):1696-704. doi: 10.1093/humrep/dem026. Epub 2007 Mar 5.

  PMID: 17339234 RESULT

MeSH Terms

Conditions

Leiomyoma

Interventions

asoprisnil

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

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 6, 2005
• First Posted: September 8, 2005
• Study Start: July 1, 2003
• Primary Completion: May 1, 2005
• Study Completion: May 1, 2005
• Last Updated: May 29, 2008

Record last verified: 2008-05