Bay98-7196, Dose Finding / POC Study

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

Overview

Key facts that identify this study and show where it stands today.

ClinicalTrials.gov ID: NCT02203331
Lead Sponsor: BayerINDUSTRY
Overall Status: Completed
Study Type: Interventional
Phase: Phase 2
Enrollment: 319Actual
Last Update Posted: Nov 7, 2023Actual
Start Date: Oct 16, 2014Actual
Primary Completion Date: Oct 24, 2016Actual
Completion Date: Oct 24, 2016Actual

Description

What the study is about and why it is being run, in the researchers' own words.

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
Brief 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

Conditions

The medical conditions and diseases this study investigates.

Endometriosis

Interventions

The treatments and procedures being evaluated in this study.

Placebo
Levonorgestrel
Anastrozole

Participation

Who can join this study and the criteria used to decide.

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No
Eligibility Criteria: 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).

Design

How the study is designed and how its participant groups are organized.

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Triple

Contacts

The people to reach with questions about this study or how to join it.

No central contacts

There are no central contacts for this study.

Locations

Where the study is run and whether each site is currently recruiting.

San Diego, California 92108, United States

Collaborators

The organizations and people involved in this study.

Lead Sponsor: BayerINDUSTRY

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