To Investigate Efficacy of YAZ in the Treatment of Dysmenorrhea

NCT02617537 | Withdrawn Phase 3

• 2 other identifiers: 164192015-003924-29
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Dysmenorrhea

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Number of participants with adverse events as measure of safety and tolerability

  Up to 16 weeks

• Number of days with dysmenorrhea

  Up to 16 weeks

• Change in dysmenorrhea score

  Baseline to week 16

• Changes from baseline to each menstrual period of total number of taken supportive analgesic medication

  Baseline to week 16

• Changes from baseline to each menstrual period of days without supportive analgesic medication.

  Baseline to week 16

Study Arms (2)

BAY86-5300

EXPERIMENTAL

Patients suffering from dysmenorrhea, treated with Yaz

Drug: EE20/DRSP(YAZ,BAY86-5300)

Placebo

PLACEBO COMPARATOR

Patients suffering from dysmenorrhea,treated with placebo

Drug: Placebo

Interventions

EE20/DRSP(YAZ,BAY86-5300) DRUG

0.02 mg EE (β-CDC)/3 mg DRSP for 24 days and placebo tablets for 4 days per 28-day intake cycle

BAY86-5300

Placebo DRUG

Matching placebo tablets for 28 days per 28-day intake cycle

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Bayer: lead

MeSH Terms

Conditions

Dysmenorrhea

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2015
• First Posted: December 1, 2015
• Study Start: January 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: October 1, 2017
• Last Updated: February 17, 2016

Record last verified: 2016-02