Overview

This trial has been completed.

Condition endometriosis
Treatments placebo, levonorgestrel, anastrozole + levonorgestrel (bay98-7196), lupron / leuprolide acetate
Phase phase 2
Sponsor Bayer
Start date October 2014
End date October 2016
Trial size 305 participants
Trial identifier NCT02203331, 15832, 2013-005090-53

Summary

Purpose of the study is to test efficacy and safety of BAY98-7196 intravaginal ring as a new treatment option for patients with endometriosis-associated pelvic pain

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Placebo Comparator)
placebo ring and placebo injection
placebo
Placebo intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection
(Experimental)
Vaginal ring containing only 170 mg levonorgestrel and placebo injection
levonorgestrel
Levonorgestrel 40 µg/d intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection
(Experimental)
Vaginal ring containing Anastrozole (50 mg) + levonorgestrel (170 mg), (low dose combination) and placebo injection
anastrozole + levonorgestrel (bay98-7196)
Anastrozole 300 µg/d + Levonorgestrel 40 µg/d intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection
(Experimental)
Vaginal ring containing Anastrozole (120 mg) + levonorgestrel (170 mg), (medium dose combination) and placebo injection
anastrozole + levonorgestrel (bay98-7196)
Anastrozole 600 µg/d + Levonorgestrel 40 µg/d intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection
(Experimental)
Vaginal ring containing Anastrozole (200 mg) + levonorgestrel (170 mg), (high dose combination) and placebo injection
anastrozole + levonorgestrel (bay98-7196)
Anastrozole 1050 µg/d + Levonorgestrel 40 µg/d intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection
(Active Comparator)
Placebo ring and leuprorelin / leuprolide acetate 11.25 mg - 3-month depot i.m. injection
lupron / leuprolide acetate
Placebo intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Lupron / Leuprolide acetate 11.25 mg 3-months depot intramuscular injection

Primary Outcomes

Measure
Absolute change in mean pain of the 7 days with worst endometriosis associated pelvic pain (EAPP) from baseline (last 28 days before randomization) to end of treatment (last 28 days of the treatment period).
time frame: baseline (last 28 days before randomization) versus end of treatment (last 28 days of the treatment period, Day 57 - 84)

Secondary Outcomes

Measure
Absolute change in mean pain of the 7 days with worst endometriosis associated pelvic pain (EAPP) from baseline (last 28 days before randomization) to the first cycle under study treatment (Day 1 - 28) and to the second cycle under study treatment.
time frame: baseline (last 28 days before randomization) vs the first cycle under study treatment (Day 1 - 28) and vs the second cycle under study treatment (Day 29 - 56)
Absolute change in mean pain from baseline (last 28 days before randomization) to the first cycle under study treatment (Day 1 - 28), the second cycle under study treatment (Day 29 - 56), and to the third cycle under study treatment (Day 57 - 84)
time frame: baseline (last 28 days before randomization) vs the first cycle under study treatment (Day 1 - 28), the second cycle under study treatment (Day 29 - 56), and the third cycle under study treatment (Day 57 - 84)
Number of days during baseline (last 28 days before randomization) and Cycles 1, 2, and 3 with pain ≥ 7 (measured on the NRS by Question 1 of the ESD)
time frame: baseline (last 28 days before randomization) and Cycles 1, 2, and 3
Change of days from baseline (last 28 days before randomization) and Cycles 1, 2, and 3 with pain ≥ 7 (measured on the NRS by Question 1 of the ESD)
time frame: baseline (last 28 days before randomization) and Cycles 1, 2, and 3
Number of days during baseline (last 28 days before randomization) and Cycles 1, 2, and 3 with pain ≥ 4 (measured on the NRS by Question 1 of the ESD)
time frame: baseline (last 28 days before randomization) and Cycles 1, 2, and 3
Change of days from baseline (last 28 days before randomization) and Cycles 1, 2, and 3 with pain ≥ 4 (measured on the NRS by Question 1 of the ESD)
time frame: baseline (last 28 days before randomization) and Cycles 1, 2, and 3

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - Premenopausal women18 years and above at the time of screening. - 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. - 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). - 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). - Willingness to use only ibuprofen as rescue pain medication for EAPP, if needed according to investigator's instruction. - 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: - Pregnancy or lactation (less than three months since delivery, abortion, or lactation before start of treatment) - 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 - Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results. - Any disease or condition that may worsen under hormonal treatment according to the assessment and opinion of the investigator. - Undiagnosed abnormal genital bleeding - Wish for pregnancy during the study - Regular use of pain medication due to other underlying diseases - Non-responsiveness of endometriosis associated pelvic pain (EAPP) to GnRH-a or surgery (partial response is not exclusionary).

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Bayer.