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Effect of a New Oral Contraceptive Pill on Hormone Related Symptoms Such as Pelvic Pain and Headache

NCT00778609 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 449

Last updated 2016-01-14

No results posted yet for this study

Summary

The aim of the present study is to investigate whether women taking a new combined oral contraceptive pill (SH T00658ID, estradiol valerate/dienogest) experience fewer hormone withdrawal-associated symptoms such as pelvic pain or headache during their monthly cycle compared to a commonly used contraceptive pill (Microgynon).

Conditions

  • Oral Contraceptive
  • Headache
  • Pelvic Pain

Interventions

DRUG

EV/DNG (Qlaira, BAY86-5027)

Estradiol valerate (EV) and dienogest (DNG). Sequential 4-phasic regimen. Daily oral administration of one capsule SH T00658ID for 28 days per cycle for 6 treatment cycles no pill-free interval

DRUG

Encapsulated Microgynon + Placebo

Day 1 to 21; 0.03 mg ethinylestradiol (EE) + 0.15 mg levonorgestrel (LNG). Day 22 to 28 placebo

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • Australia
  • Finland
  • France
  • Germany
  • Mexico
  • Spain
  • Switzerland
  • Thailand
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
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 NCT00778609 on ClinicalTrials.gov