Efficacy and safety of a progestin and an aromatase inhibitor combined in a intravaginal ring in symptomatic endometriosis.

Phase 1

• Conditions: Endometriosis; MedDRA version: 19.0Level: LLTClassification code 10014788Term: Endometriosis related painSystem Organ Class: 10038604 - Reproductive system and breast disorders; MedDRA version: 19.0Level: PTClassification code 10014778Term: EndometriosisSystem Organ Class: 10038604 - Reproductive system and breast disorders; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2013-005090-53-AT
• Lead Sponsor: Bayer AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08-07
• Last Update Posted: 21 November 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 318

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 318
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 clinical trial of medicinal product
• Study Design: Not specified