Clinical trial NCT00150644: A Study to Evaluate the Effects of Asoprisnil(J867) in Women With Uterine Fibroids Who Are Scheduled for a Hysterectomy
Official title: A Phase 2, 12-Week, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Effects of J867 on Uterine Artery Blood Flow and the Morphology of the Endometrium, Myometrium, and Uterine Leiomyomata in Subjects With Uterine Leiomyomata Scheduled for Hysterectomy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Uterine Fibroids
Leiomyoma
Keywords: Fibroid Uterus
Leiomyoma
Uterine Fibroids
Hysterectomy
Asoprisnil
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2005-09-08
Enrollment: 33
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: No medical therapy is currently available for the long-term treatment of uterine fibroids. The objective of this study is to determine the effects of asoprisnil in uterine fibroid growth suppression. Full thickness biopsies obtained from surgical procedures will allow the assessment of asoprisnil's effects on the basalis, the myometrium, and on endometrial angiogenesis. Various other exploratory immunohistological and biochemical specimens will be collected to evaluate the mechanisms of action of asoprisnil in the endometrium, the myometrium, and in uterine fibroids.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change from baseline to the Final Visit in uterine artery blood flow as determined by change in Resistance Index.
timeFrame: Final visit
Secondary outcomes:
measure: Change from baseline in uterine artery blood flow as determined by change in Pulsatility Index.
timeFrame: Final Visit
measure: Morphological changes in the endometrium, myometrium and uterine fibroids.
timeFrame: Final Visit
measure: Change from baseline in menstrual pictogram score.
timeFrame: Final Month
measure: Percent change from baseline in volume of the largest fibroid.
timeFrame: Final Visit
measure: Endometrial thickness (post-treatment histologic evaluation).
timeFrame: Final Visit
measure: Change from baseline in endometrial thickness by transvaginal ultrasound.
timeFrame: Final Visit
measure: Percent of ovulatory subjects.
timeFrame: Final Month
measure: Change from baseline in the Uterine Fibroid Symptom-Quality of Life total symptom severity score and the Uterine Fibroid Symptom-Quality of Life total score.
timeFrame: Final Visit
Other outcomes:
Locations:
Study officials:
affiliation: Abbott
name: Medical Director
role: STUDY_CHAIR
References:
citation: 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.