A randomized, placebo-controlled, double-blind, parallel-group, multi-center, exploratory dose-response study to assess the efficacy and safety of different oral doses of BAY1128688 in women with symptomatic endometriosis over a 12-week treatment period
- Conditions
- pain during intercourse ('dyspareunia') and non-cyclic pelvic pain.Well-accepted lay language synomyms for endometriosis are not known to us. Endometriosis describes the presence of endometrium elsewhere than in the lining of the uterus. It is associated with pelvic pain during menstruation called 'dysmenorrhea'10038612
- Registration Number
- NL-OMON46660
- Lead Sponsor
- Bayer
- Brief Summary
Trial ended prematurely
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 5
- Women of at least 18 years of age at the time of signing of informed consent.
- Women with endometriosis confirmed by at least one of the two criteria:
-- surgery within the last 10 years
-- imaging within the last 12 months
- moderate to severe pelvic pain which will be assessed over a period of 28 days
- Willingness to use only ibuprofen as rescue pain medication for endometriosis-associated pelvic pain.
- Willingness to use non-hormonal barrier method for contraception (here spermicide-coated condoms) from screening visit until the end of the study (unless adequate contraception is achieved by vasectomy of the partner or use of copper intrauterine device [IUD] or commitment to
abstinence) and to refrain from using hormonal contraception.
- Pregnancy or lactation (more than three months since delivery, abortion, or lactation before start of treatment) AND no wish for pregnancy during the study.
- Altered bilirubin metabolism and liver function at Visit 1.
- Requirement to use pain medications for reasons other than endometriosis.
- Contraindications to using ibuprofen.
- Signs of hyperandrogenism.
- Absence of menstrual cycles and/or abnormal vaginal/genital bleeding
- History of hysterectomy, tubal-ligation or bilateral ovariectomy
- Uncontrolled thyroid disorder
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary objective: Explore the dose response relationship of different doses of<br /><br>BAY 1128688 compared to placebo in the treatment of endometriosis-related<br /><br>symptoms over a 12-week treatment period </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary objective: Assessment of safety and tolerability of BAY 1128688 over<br /><br>a 12-week treatment period </p><br>