A randomized, double-blind, double-dummy, parallel- group, multi-center phase IIb study to assess the efficacy and safety of different dose combinations of an aromatase inhibitor and a progestin in an intravaginal ring versus placebo and leuprorelin / leuprolide acetate in women with symptomatic endometriosis over a 12-week treatment period

Phase 2

Completed

Conditions: endometriosis
gynecological disorder in the reproductive female system
10038612

Registration Number: NL-OMON42171

Lead Sponsor: Bayer

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

1. Signed and dated informed consent.
2. Premenopausal women18 years and above at the time of screening.
3. Women with endometriosis confirmed by laparoscopy or laparotomy within the last ten years but not less than 8 weeks before the screening visit
In Japan, diagnosis based on imaging (transvaginal ultrasound or MRI) also qualifies for inclusion.
4. Moderate to severe endometriosis-associated pelvic pain (EAPP) of >=5 in the last 28 days before screening visit 1 measured on the numeric rating scale (NRS; i.e. 4-week recall period).
5. At randomization: Adherence to the study procedures during the screening period, at least 24 diary entries of ESD item 1 during the last 28 consecutive days before the randomization visit, and a sum of the available ESD item 1 (*worst pain* on the daily NRS) entries during this period of at least 98 (corresponding to an average score of >= 3.5).
6. Willingness to use only ibuprofen as rescue pain medication for EAPP, if needed according to investigator*s instruction.
7. Use of a non-hormonal barrier method (i.e. spermicide-coated condoms) for contraception from screening visit until the end of the study. This is not required if adequate contraception is achieved by vasectomy of the partner.

Exclusion Criteria

1. Pregnancy or lactation (less than three months since delivery, abortion, or lactation before start of treatment)
2. Any diseases or conditions that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug
3. Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results.
4. Any disease or condition that may worsen under hormonal treatment according to the assessment and opinion of the investigator.
5. Undiagnosed abnormal genital bleeding
6. Wish for pregnancy during the study
7. Regular use of pain medication due to other underlying diseases
8. Non-responsiveness of endometriosis associated pelvic pain (EAPP) to GnRH-a or surgery (partial response is not exclusionary).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To assess the dose-response relationship and demonstrate efficacy of BAY<br /><br>98-7196 vs. placebo in women with symptomatic endometriosis</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- To identify at least 1 superior effective dose of BAY 98-7196 compared to<br /><br>placebo<br /><br>- To compare the efficacy of BAY 98-7196 versus leuprorelin / leuprolide<br /><br>acetate descriptively<br /><br>- To assess sustainability of treatment effect and recurrence of symptoms<br /><br>- To evaluate the safety and tolerability of BAY 98-7196 in women with<br /><br>symptomatic endometriosis<br /><br>- To explore sub-populations (e.g. subjects with indication for treatment with<br /><br>a gonadotropin-releasing hormone agonist or surgery as judged by the<br /><br>investigator or by endometriosis history and symptom severity)</p><br>