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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02617537
Other study ID # 16419
Secondary ID 2015-003924-29
Status Withdrawn
Phase Phase 3
First received November 23, 2015
Last updated February 15, 2016
Start date January 2016
Est. completion date October 2017

Study information

Verified date February 2016
Source Bayer
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical DevicesRussia: Federal Service on Surveillance in Health Care
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date October 2017
Est. primary completion date September 2017
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
EE20/DRSP(YAZ,BAY86-5300)
0.02 mg EE (ß-CDC)/3 mg DRSP for 24 days and placebo tablets for 4 days per 28-day intake cycle
Placebo
Matching placebo tablets for 28 days per 28-day intake cycle

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Bayer

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Number of participants with adverse events as measure of safety and tolerability Up to 16 weeks Yes
Secondary Number of days with dysmenorrhea The occurrence of dysmenorrhea will be recorded in the patient diary Up to 16 weeks No
Secondary 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 No
Secondary 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 No
Secondary Changes from baseline to each menstrual period of days without supportive analgesic medication. Baseline to week 16 No
Secondary 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 No
Secondary 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 No
Secondary 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 No
Secondary 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 No
Secondary 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 No
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