To Investigate Efficacy of YAZ in the Treatment of Dysmenorrhea

A Multinational, Double-blind, Randomized, Placebo-controlled, Parallel-group Clinical Study to Investigate the Efficacy and Safety of the Oral Hormonal Contraceptive BAY 86-5300 (0.02 mg Ethinyl Estradiol as Betadex Clathrate and 3 mg Drospirenone) Over 16 Weeks for the Treatment of Women With Dysmenorrhea

The objective of this study is to investigate the safety and efficacy of (0.02 mg EE as betadex clathrate [β-CDC]) / 3 mg drospirenone (DRSP) for dysmenorrhea. In order to appropriately evaluate the efficacy of EE(β-CDC)/DRSP the study was set up as a placebo-controlled comparative study

Study Overview

• Status: Withdrawn
• Conditions: Dysmenorrhea
• Intervention / Treatment: Drug: EE20/DRSP(YAZ,BAY86-5300); Drug: Placebo

• Study Type: Interventional
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Patients suffering from dysmenorrhea for at least the previous 3 months prior to Visit 1 with a minimum visual analogue scale (VAS) score of 30 mm with regard to pain during the menstrual period of the screening period
• Good general health (except for findings related to dysmenorrhea) as proven by medical history
• Patients aged 18 years or older at the time of obtaining informed consent; smokers must not be older than 35 years at the time point of informed consent
• Normal or clinically insignificant cervical smear not requiring further follow up (a cervical smear has to be taken at screening visit or a normal result has to be documented within the previous six months). Human papilloma virus (HPV) testing in subjects with atypical squamous cells of undetermined significance (ASCUS) can be used as an adjunctive test. Subjects with ASCUS can be included if they are negative for high-risk HPV strains (HPV 16, HPV18).
• Women of childbearing potential must agree that adequate contraception will be used when they are sexually active. This applies from signing of the informed consent form until 2 weeks after the last study drug administration.

Exclusion Criteria:

• Pregnancy (confirmed or suspected) or lactation (less than three months since delivery, abortion, or lactation before start of treatment)
• Patients who wish to become pregnant during the course of the study
• Body Mass Index (BMI) > 32 kg/m2
• Hypersensitivity to any ingredient of the study drug
• Laboratory values outside inclusion range before randomization
• 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 medication
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: BAY86-5300; Patients suffering from dysmenorrhea, treated with Yaz	Drug: EE20/DRSP(YAZ,BAY86-5300); 0.02 mg EE (β-CDC)/3 mg DRSP for 24 days and placebo tablets for 4 days per 28-day intake cycle
PLACEBO_COMPARATOR: Placebo; Patients suffering from dysmenorrhea,treated with placebo	Drug: Placebo; Matching placebo tablets for 28 days per 28-day intake cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in visual analogue scale (VAS) score for pain due to dysmenorrhea from baseline to Visit 6	The patient marks the individual pain impression on a visual analogue scale in the range 0 (no pain) to 100mm (worst pain ever experienced)	Baseline to week 17

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse events as measure of safety and tolerability		Up to 16 weeks
Number of days with dysmenorrhea	The occurrence of dysmenorrhea will be recorded in the patient diary	Up to 16 weeks
Change in dysmenorrhea score	It is the sum of two four-stage sub-scales which assess the extent to which dysmenorrhea interferes with daily life & the extent to which pain medication is used.	Baseline to week 16
Changes from baseline to each menstrual period of total number of taken supportive analgesic medication	Standard Analgesic tablets are provided to participants	Baseline to week 16
Changes from baseline to each menstrual period of days without supportive analgesic medication.		Baseline to week 16
Clinical Global Impression(CGI)	The CGI is the measure of global improvement index from the opinion of the investigator and subject to document changes in the health status during treatment	At week 16
Self administered SF-36 questionnaire	The 36-items Short Form Health Survey (SF-36) (version 2.0) is a set of generic, coherent,and easily administered quality-of-life measures.	At baseline and week 17
Changes from baseline to each menstrual period of severity of lumbago	The patient classifies the severity on a mild, moderate, severe scale	Up to 16 weeks
Changes from baseline to each menstrual period of severity of headache	The patient classifies the severity on a mild, moderate, severe scale	Up to 16 weeks
Changes from baseline to each menstrual period of severity of nausea/vomiting	The patient classifies the severity on a mild, moderate, severe scale	Up to 16 weeks

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (ANTICIPATED): September 1, 2017
• Study Completion (ANTICIPATED): October 1, 2017

Study Registration Dates

• First Submitted: November 23, 2015
• First Submitted That Met QC Criteria: November 26, 2015
• First Posted (ESTIMATE): December 1, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): February 17, 2016
• Last Update Submitted That Met QC Criteria: February 15, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Menstruation Disturbances; Pelvic Pain; Dysmenorrhea
• Other Study ID Numbers: 16419 (Other Identifier: City of Hope Medical Center); 2015-003924-29 (EUDRACT_NUMBER)