Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Leiomyoma

Myofibroma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Connective Tissue

Connective Tissue Diseases

PK arm requires one additional 24 hour PK assessment at V3 and daily visits between visits 2 and 3 for drug trough sample collection

12 mg, vaginal capsule, once daily for 4 months

telepristone acetate 12 mg

3 mg, vaginal capsule, once daily for 3 months

telepristone acetate 3 mg

6 mg, vaginal capsule, once daily for 3 months

telepristone acetate 6 mg

12 mg, vaginal capsule, once daily, for 3 months

24 mg, vaginal capsule, once daily for 4 months

telepristone acetate 24 mg

The purpose of this study is to determine the safety, pharmacokinetics and efficacy of four doses of vaginally administered Proellex in premenopausal women with uterine fibroids confirmed by ultrasound.

Extension of Study ZPV-200

A Phase 2, Multi-Center, Five-Arm, Parallel Design, Randomized, Single-Blind Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Proellex® (Telapristone Acetate) Administered Vaginally in the Treatment of Premenopausal Women With Uterine Fibroids Confirmed by Ultrasound

The primary efficacy endpoint will be bleeding assessed using the change in PBAC scores from the 4 weeks prior to Visit 2 to the 4 weeks prior to Visit 10

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Extension of Study ZPV-200	NCT01631903	Uterine Fibroid...	telepristone ac... telepristone ac... telepristone ac... telepristone ac... telepristone ac...	18 Years - 47 Years	Repros Therapeutics Inc.
Extension of Study ZPV-200	NCT01631903	Uterine Fibroid...	telepristone ac... telepristone ac... telepristone ac... telepristone ac... telepristone ac...	18 Years - 47 Years	Repros Therapeutics Inc.

Spots Global Cancer Trial Database for telepristone acetate 6 mg