NCT01069094

Brief Summary

A study of 3 doses of Progenta versus placebo versus Lucron Depot for treatment of leiomyomata.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2004

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

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, 2004

Completed
6 months 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
5.1 years until next milestone

First Submitted

Initial submission to the registry

February 12, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 17, 2010

Completed
Last Updated

June 30, 2014

Status Verified

June 1, 2014

Enrollment Period

6 months

First QC Date

February 12, 2010

Last Update Submit

June 27, 2014

Conditions

Uterine Leiomyomata

Keywords

Uterine fibroids

Outcome Measures

Primary Outcomes (1)

  • Assess the safety of Progenta when administered in pre-menopausal women with symptomatic leiomyomata.

    90 days

Secondary Outcomes (1)

  • Determine the tolerability of three doses of Progenta (12.5 mg, 25 mg, and 50 mg) as compared to placebo and Lucron Depot (leuprolide acetate for depot suspension) in pre-menopausal women with symptomatic leiomyomata.

    90 days

Study Arms (5)

progenta 12.5 mg

EXPERIMENTAL

Progenta (CDB-4124) 12.5 mg capsule

Drug: Progenta

progenta 25 mg

EXPERIMENTAL

Progenta (CDB-4124) 25 mg capsule

Drug: Progenta

progenta 50 mg

EXPERIMENTAL

Progenta (CDB-4124) 50 mg capsule

Drug: Progenta

Lucron Depot

ACTIVE COMPARATOR

Lucron Depot, Leuprolide acetate for depot suspension

Drug: Lucron Depot

placebo

PLACEBO COMPARATOR

Placebo capsule

Drug: Placebo

Interventions

ProgentaDRUG

12.5 mg, administered as a once daily oral dose for 90 days.

Also known as: CDB-4124, Telapristone acetate
progenta 12.5 mg
Lucron DepotDRUG

3.75 mg IM monthly

Also known as: leuprolide acetate for depot suspension
Lucron Depot
PlaceboDRUG

Administered as a once daily oral dose for 90 days.

placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Had at least one leiomyomata lesion that was identifiable and measurable by transvaginal ultrasound.
  • Had a regular or steady menstrual cycle lasting from 24 to 36 days.

You may not qualify if:

  • Post-menopausal
  • Subject with documented endometriosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University /MTZ Clinical Research Sp.zo.o.

Warsaw, 02-106, Poland

Location

MeSH Terms

Conditions

MyofibromaLeiomyoma

Interventions

telapristone acetateLeuprolide

Condition Hierarchy (Ancestors)

Neoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsConnective Tissue DiseasesSkin and Connective Tissue DiseasesNeoplasms, Muscle Tissue

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Ronald Wiehle, PhD

    Repros Therapeutics Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2010

First Posted

February 17, 2010

Study Start

July 1, 2004

Primary Completion

January 1, 2005

Study Completion

January 1, 2005

Last Updated

June 30, 2014

Record last verified: 2014-06

Locations

PL(1)