NCT00152269

Brief Summary

The objective of this study is to determine the safety and effectiveness of asoprisnil in symptomatic women with abnormal uterine bleeding associated with uterine fibroids.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
475

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jul 2002

Typical duration for phase_3

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

July 1, 2002

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
8 months 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

2.5 years

First QC Date

September 7, 2005

Last Update Submit

May 27, 2008

Conditions

LeiomyomaMenorrhagiaMetrorrhagia

Keywords

Symptomatic Uterine FibroidsExcessive Uterine BleedingUterine Hemorrhageasoprisnil

Outcome Measures

Primary Outcomes (1)

  • The percent of subjects who demonstrate a clinically meaningful improvement in bleeding and do not have surgical/invasive intervention.

    Month 12 or Final Visit

Secondary Outcomes (8)

  • Percent of subjects with clinically meaningful improvement in bleeding and who do not require surgical/invasive intervention.

    Month 6

  • Change from baseline in menstrual pictogram score.

    Final Month

  • Change from baseline in number of days with bleeding.

    Final Month

  • Change from baseline in hemoglobin concentration.

    Final Visit

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

    Final Visit

  • +3 more secondary outcomes

Study Arms (3)

1

EXPERIMENTAL
Drug: Asoprisnil

2

EXPERIMENTAL
Drug: Asoprisnil

3

PLACEBO COMPARATOR
Drug: Placebo

Interventions

AsoprisnilDRUG

10mg Tablet, oral Daily for 12 months

1
PlaceboDRUG

Placebo, Tablet, oral Daily for 12 months

3

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Premenopausal women
  • History of regular menstrual cycles (21-42 days)
  • Diagnosis of uterine fibroid(s)
  • Abnormal vaginal bleeding associated with uterine fibroids
  • Otherwise in good health
  • Agrees to undergo surgery (hysterectomy) or any other invasive procedure if the study medication fails
  • Negative pregnancy test
  • Agrees to Double-barrier method of contraception
  • Pap smear with no evidence of malignancy or pre-malignant changes
  • Endometrial biopsy with no significant histological disorder

You may not qualify if:

  • Any abnormal lab or procedure result the study-doctor considers important
  • Severe reaction(s) to or are currently using any hormone therapy
  • History of osteoporosis or other bone disease
  • Previous myomectomy with 1 year and/or previous uterine artery embolization within 6 months
  • History of Polycystic Ovary Syndrome or prolactinoma
  • MRI shows significant gynecologic disorder
  • Uterine size \> 25 weeks gestation
  • Hemoglobin \< 8 g/dL at Day -1

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Stewart EA, Diamond MP, Williams ARW, Carr BR, Myers ER, Feldman RA, Elger W, Mattia-Goldberg C, Schwefel BM, Chwalisz K. Safety and efficacy of the selective progesterone receptor modulator asoprisnil for heavy menstrual bleeding with uterine fibroids: pooled analysis of two 12-month, placebo-controlled, randomized trials. Hum Reprod. 2019 Apr 1;34(4):623-634. doi: 10.1093/humrep/dez007.

    PMID: 30865281DERIVED

  • Larsen L, Coyne K, Chwalisz K. Validation of the menstrual pictogram in women with leiomyomata associated with heavy menstrual bleeding. Reprod Sci. 2013 Jun;20(6):680-7. doi: 10.1177/1933719112463252. Epub 2012 Nov 27.

    PMID: 23188490DERIVED

MeSH Terms

Conditions

LeiomyomaMenorrhagiaMetrorrhagiaUterine Hemorrhage

Interventions

asoprisnil

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsMenstruation Disturbances

Study Officials

  • Medical Director

    Abbott

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 9, 2005

Study Start

July 1, 2002

Primary Completion

January 1, 2005

Study Completion

January 1, 2005

Last Updated

May 29, 2008

Record last verified: 2008-05