Condition

Endometriosis

Compensation

Up to $1400

Duration

18 Visits

Endometriosis

Official Title

Assess Safety and Efficacy of Vilaprisan in Subjects With Endometriosis (VILLENDO)

Study Summary

The primary objective of this study is to assess the efficacy and safety of two doses of vilaprisan compared to placebo in women with symptomatic endometriosis. The secondary objective of this study is to evaluate the safety and tolerability of two different doses of vilaprisan in women with symptomatic endometriosis.

Eligibility and Recruitment Information

Recruitment Status Recruiting
Eligible Genders Female
Eligible Ages 18 and Older
Inclusion Pre-menopausal women 18 years (inclusive) and above at the time of Visit 1 Women with endometriosis confirmed by laparoscopy or laparotomy OR diagnosed based on imaging Moderate to severe endometriosis-associated pelvic pain (EAPP) Willingness to use only standardized pain medication if needed Good general health (except for findings related to endometriosis) Willingness / ability to comply with electronic diary entry for the duration of study participation
Exclusion Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before Visit 1) Undiagnosed abnormal genital bleeding Abuse of alcohol, drugs, or medicines (e.g. laxatives) as evaluated by the investigator Inability to cooperate with the study procedures for any reason Regular use of pain medication due to other underlying diseases
Start Date November 15, 2018
Compensation Up to $1400
Location Orlando, FL

Study Information

Condition Endometriosis

Administrative Information

Study ID NCT03573336

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