To Investigate Efficacy of YAZ in the Treatment of Dysmenorrhea

Phase 3

Withdrawn

• Conditions: Dysmenorrhea
• Interventions: Drug: Placebo; Drug: EE20/DRSP(YAZ,BAY86-5300)

• Registration Number: NCT02617537
• Lead Sponsor: Bayer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-23
• Study First Submitted QC: 2015-11-26
• Study First Posted: 2015-12-01
• Study Start: 2016-01
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-15
• Last Update Posted: 2016-02-17
• Primary Completion: 2017-09
• Study Completion: 2017-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Patients suffering from dysmenorrhea,treated with placebo
BAY86-5300	EE20/DRSP(YAZ,BAY86-5300)	Patients suffering from dysmenorrhea, treated with Yaz

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of days with dysmenorrhea	Up to 16 weeks	The occurrence of dysmenorrhea will be recorded in the patient diary
Changes from baseline to each menstrual period of total number of taken supportive analgesic medication	Baseline to week 16	Standard Analgesic tablets are provided to participants
Number of participants with adverse events as measure of safety and tolerability	Up to 16 weeks
Changes from baseline to each menstrual period of severity of lumbago	Up to 16 weeks	The patient classifies the severity on a mild, moderate, severe scale
Change in dysmenorrhea score	Baseline to week 16	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.
Clinical Global Impression(CGI)	At week 16	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
Self administered SF-36 questionnaire	At baseline and week 17	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.
Changes from baseline to each menstrual period of severity of headache	Up to 16 weeks	The patient classifies the severity on a mild, moderate, severe scale
Changes from baseline to each menstrual period of days without supportive analgesic medication.	Baseline to week 16
Changes from baseline to each menstrual period of severity of nausea/vomiting	Up to 16 weeks	The patient classifies the severity on a mild, moderate, severe scale