Terminated/Withdrawn

Dysmenorrhea

Bayer Identifier:

16419

ClinicalTrials.gov Identifier:

NCT02617537

EudraCT Number:

2015-003924-29

EU CT Number:

Not Available

To investigate efficacy of YAZ in the treatment of dysmenorrhea

Trial purpose

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

Key Participants Requirements

Sex

Female

Age

18 - N/A

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.

Trial summary

Enrollment Goal

Trial Dates

January 2016 - October 2017

Phase

Phase 3

Could I Receive a placebo

Yes

Products

YAZ (EE20/DRSP, BAY86-5300)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Withdrawn	Shanghai Tongji Hospital of Tongji University	Shanghai, China

Primary Outcome

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)
Time Frame:
Baseline to week 17
Safety Issue:
No

Secondary Outcome

Number of participants with adverse events as measure of safety and tolerability
Time Frame:
Up to 16 weeks
Safety Issue:
Yes
Number of days with dysmenorrhea
The occurrence of dysmenorrhea will be recorded in the patient diary
Time Frame:
Up to 16 weeks
Safety Issue:
No
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.
Time Frame:
Baseline to week 16
Safety Issue:
No
Changes from baseline to each menstrual period of total number of taken supportive analgesic medication
Standard Analgesic tablets are provided to participants
Time Frame:
Baseline to week 16
Safety Issue:
No
Changes from baseline to each menstrual period of days without supportive analgesic medication.
Time Frame:
Baseline to week 16
Safety Issue:
No
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
Time Frame:
At week 16
Safety Issue:
No
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.
Time Frame:
At baseline and week 17
Safety Issue:
No
Changes from baseline to each menstrual period of severity of lumbago
The patient classifies the severity on a mild, moderate, severe scale
Time Frame:
Up to 16 weeks
Safety Issue:
No
Changes from baseline to each menstrual period of severity of headache
The patient classifies the severity on a mild, moderate, severe scale
Time Frame:
Up to 16 weeks
Safety Issue:
No
Changes from baseline to each menstrual period of severity of nausea/vomiting
The patient classifies the severity on a mild, moderate, severe scale
Time Frame:
Up to 16 weeks
Safety Issue:
No

Trial design

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

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

Randomized

Blinding

Double Blind

Assignment

Parallel Assignment

Trial Arms

Additional Information

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