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Comparative Trial in Hormone Withdrawal Associated Symptoms

NCT01076582 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 592

Last updated 2014-10-28

No results posted yet for this study

Summary

This clinical research study will examine whether an oral contraceptive pill taken with a monthly hormone-free interval of 4 days reduces hormone withdrawal associated symptoms compared to an oral contraceptive pill taken with a monthly hormone-free interval of 7 days after 4 cycles of treatment.

Conditions

  • Oral Contraceptive

Interventions

DRUG

EE20/DRSP (YAZ, BAY86-5300)

4 cycles of treatment / per cycle: 1 tablet (EE 0.02 mg / DRSP 3 mg) daily for 24 days followed by 1 placebo tablet daily for 4 days

DRUG

Ethinylestradiol (EE) and desogestrel (DSG) (Mercilon)

4 cycles of treatment / per cycle: 1 tablet (EE 0.02 mg / DSG 0.15 mg) daily for 21 days followed by 1 placebo tablet daily for 7 days

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • Argentina
  • Chile
  • Colombia
  • Czechia
  • Germany
  • Italy
  • Philippines
  • Portugal
  • Russia
  • South Korea
  • Switzerland
  • Thailand
  • United Kingdom
  • Venezuela

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01076582 on ClinicalTrials.gov