Clinical trial NCT02617537: To Investigate Efficacy of YAZ in the Treatment of Dysmenorrhea
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Dysmenorrhea
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2015-12-01
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Mean change in visual analogue scale (VAS) score for pain due to dysmenorrhea from baseline to Visit 6
timeFrame: Baseline to week 17
Secondary outcomes:
measure: Number of participants with adverse events as measure of safety and tolerability
timeFrame: Up to 16 weeks
measure: Number of days with dysmenorrhea
timeFrame: Up to 16 weeks
measure: Change in dysmenorrhea score
timeFrame: Baseline to week 16
measure: Changes from baseline to each menstrual period of total number of taken supportive analgesic medication
timeFrame: Baseline to week 16
measure: Changes from baseline to each menstrual period of days without supportive analgesic medication.
timeFrame: Baseline to week 16
measure: Clinical Global Impression(CGI)
timeFrame: At week 16
measure: Self administered SF-36 questionnaire
timeFrame: At baseline and week 17
measure: Changes from baseline to each menstrual period of severity of lumbago
timeFrame: Up to 16 weeks
measure: Changes from baseline to each menstrual period of severity of headache
timeFrame: Up to 16 weeks
measure: Changes from baseline to each menstrual period of severity of nausea/vomiting
timeFrame: Up to 16 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: