Safety and Efficacy Study to Evaluate Proellex in the Treatment of Premenopausal Women With Symptomatic Endometriosis

Repros Therapeutics

Status and phase: Terminated; Phase 2

Conditions: Endometriosis

Treatments: Drug: Proellex 50 mg; Drug: Proellex 25 mg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00556075

ZPE-201

Details and patient eligibility

About

The purpose of this study is to determine whether Proellex is safe and effective for the treatment of symptomatic endometriosis.

Enrollment: 67 patients

Sex: Female

Ages: 18 to 48 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Premenopausal women aged 18-48 inclusive
• Endometriosis documented by laparoscopic or surgical assessment within the past ten (10) years
• Clinical symptoms of endometriosis for at least the past three (3) months
• Endometriosis symptoms
• Must be sexually active unless sexually inactive for endometriosis-related dyspareunia
• Must have a regular or steady menstrual cycle lasting from 24 to 36 days and a detectable ovulation during the baseline period using an ovulation monitoring kit (for timing of endometrial biopsy)
• Other inclusion criteria may apply

Exclusion criteria

• Six (6) months or more without a menstrual period, or
• Prior hysterectomy or
• Prior bilateral oophorectomy
• Diagnosis of osteopenia
• Present history or condition that causes non-endometriosis-related dyspareunia
• Presence of excessive bleeding or menorrhagia
• Abnormal screening endometrial biopsy
• Other exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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67 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo once daily

Treatment:

Drug: Placebo

25 mg

Experimental group

Description:

Proellex 25 mg once daily

Treatment:

Drug: Proellex 25 mg

50 mg

Experimental group

Description:

Proellex 50 mg once daily

Treatment:

Drug: Proellex 50 mg