NCT00683917

Brief Summary

PK of 25 mg and 50 mg Proellex® administered once daily (QD) over a 4-month period.

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2008

Shorter than P25 for phase_2

Geographic Reach
2 countries

4 active sites

Status
terminated

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

May 1, 2008

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

May 22, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 26, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
5.1 years until next milestone

Results Posted

Study results publicly available

August 21, 2014

Completed
Last Updated

August 21, 2014

Status Verified

August 1, 2014

Enrollment Period

1.3 years

First QC Date

May 22, 2008

Results QC Date

June 25, 2014

Last Update Submit

August 5, 2014

Conditions

Uterine Fibroids

Keywords

Uterine fibroidsFibroids

Outcome Measures

Primary Outcomes (1)

  • The Primary Outcome Measure is the PK Characteristics of 25 mg and 50 mg Proellex.

    4 months

Study Arms (3)

Proellex 25 mg

EXPERIMENTAL

Proellex 25 mg

Drug: Proellex 25 mg

Proellex 50 mg

EXPERIMENTAL

Proellex 50 mg

Drug: Proellex 50 mg

Lupron

ACTIVE COMPARATOR

Lupron Depot

Drug: Lupron Depot

Interventions

Proellex 25 mgDRUG

Proellex 25 mg, 1 capsule daily for 4 months

Also known as: Telapristone acetate
Proellex 25 mg
Proellex 50 mgDRUG

Proellex 50 mg, 2 capsules daily for 4 months

Also known as: Telapristone acetate
Proellex 50 mg
Lupron DepotDRUG

Lupron 3.75 mg monthly intramuscular injections for 4 months

Also known as: Leuprolide acetate
Lupron

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Female subjects between the ages of 18 and 45 years with body mass index (BMI) between 18 and 35 mg/kg2 inclusive
  • Surgical interventions for uterine fibroids (e.g., hysterectomy, myomectomy, or uterine arterial embolization) must not be planned or anticipated during the study
  • Subject must have the following uterine fibroid-associated symptom: history of excessive menstrual bleeding
  • Regular or steady menstrual cycle lasting from 24 to 36 days
  • Willing to comply with all study procedures including the endometrial biopsies and PK blood draws for all visits including follow-up visits
  • Subject must agree to use a medically acceptable and effective non-hormonal, double barrier birth control method throughout the study and for 30 days following the end of the study or discontinuation of study drug

You may not qualify if:

  • Documented endometriosis or active pelvic inflammatory disease
  • History of alcohol and/or drug abuse
  • Any history or diagnosis of gynecological cancer or cervical dysplasia
  • Use of an IUD
  • Use of prohibited concomitant medications:
  • Use of Depo-Provera must cease 10 months prior to first dose of study drug
  • Use of GnRH agonists (e.g., Lupron®) must cease 4 months prior to first dose of study drug and Lupton® Depot 8 months prior to the first visit
  • Known active infection with HIV; Hepatitis A, B or C; gonorrhea; or chlamydia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Physician Care Clinical Research

Sarasota, Florida, 34239, United States

Location

Advances in Health, Inc.

Houston, Texas, 77030, United States

Location

West Houston Clinical Research Services

Houston, Texas, 77055, United States

Location

Centro de Estudios Cientificos y Clinicos Pharma, S.A. de C.V. (CECYC-Pharma)

Mexico City, Federal District, 03100, Mexico

Location

MeSH Terms

Conditions

Leiomyoma

Interventions

telapristone acetateLeuprolide

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Limitations and Caveats

The study was prematurely terminated for safety reasons (Proellex studies were put on clinical hold due to liver toxicity). Sponsor was unable to pay vendor, and was therefore not provided with any study data.

Results Point of Contact

Title
Jennifer Wike
Organization
Repros Therapeutics Inc.
jwike@reprosrx.com
2817193402

Study Officials

  • Andre vanAs, MD, PhD

    Repros Therapeutics Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2008

First Posted

May 26, 2008

Study Start

May 1, 2008

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

August 21, 2014

Results First Posted

August 21, 2014

Record last verified: 2014-08

Locations

US(3)ME(1)