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

January 13, 2016 updated by: Bayer

A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Group, 2-arm Study to Show Superiority of the Oral Contraceptive SH T00658ID Over Microgynon on Hormone Withdrawal-associated Symptoms After 6 Cycles of Treatment

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

449

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Ashfield, New South Wales, Australia, 2031
      • Blacktown, New South Wales, Australia, 2148
      • Caringbah, New South Wales, Australia, 2229
      • Sydney, New South Wales, Australia, 2031
    • Queensland
      • Fortitude Valley, Queensland, Australia, 4006
      • Kipparing, Queensland, Australia, 4021
    • South Australia
      • Adelaide, South Australia, Australia, 5005
      • Norwood, South Australia, Australia, 5065
    • Victoria
      • Clayton, Victoria, Australia, 3163
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
      • Subiaco, Western Australia, Australia, 6008
  • Finland
      • Helsinki, Finland, 00260
      • Helsinki, Finland, 00100
      • Helsinki, Finland, 00350
      • Kuopio, Finland, 70100
      • Kuopio, Finland, 70110
  • France
      • Brignoles, France, 83170
      • Maison Lafitte, France, 78600
      • Nancy, France, 54042
      • Nantes, France, 44093
      • Nantes, France, 44000
      • Olivet, France, 45160
      • Paris, France, 75018
      • Paris, France, 75015
      • Paris, France, 75007
      • Saint Germain En Laye, France, 78100
      • Seclin, France, 59113
      • Tarare, France, 69170
      • Toulouse, France, 31000
  • Germany
      • Hamburg, Germany, 22359
    • Baden-Württemberg
      • Rheinstetten, Baden-Württemberg, Germany, 76287
    • Hessen
      • Frankfurt, Hessen, Germany, 60322
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30459
    • Nordrhein-Westfalen
      • Bochum, Nordrhein-Westfalen, Germany, 44787
      • Essen, Nordrhein-Westfalen, Germany, 45127
      • Wuppertal, Nordrhein-Westfalen, Germany, 42103
    • Sachsen
      • Dresden, Sachsen, Germany, 01067
      • Leipzig, Sachsen, Germany, 04103
    • Sachsen-Anhalt
      • Magdeburg, Sachsen-Anhalt, Germany, 39126
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Germany, 23538
  • Mexico
      • Mexico, D.F., Mexico, 3100
      • México, D.F., Mexico, 07760
    • México
      • Mexico, México, Mexico, 06700
    • Sonora
      • Hermosillo, Sonora, Mexico, 83100
  • Spain
      • Barcelona, Spain, 08013
      • Madrid, Spain, 28001
    • Alicante
      • Benidorm, Alicante, Spain, 03503
      • Petrer, Alicante, Spain, 03610
    • Asturias
      • Gijón, Asturias, Spain, 33212
    • Catalunya
      • Barcelona, Catalunya, Spain, 08003
  • Switzerland
      • Bern, Switzerland, 3010
      • Bern, Switzerland, 3013
      • Zürich, Switzerland, 8091
    • Basel-Stadt
      • Basel, Basel-Stadt, Switzerland, 4031
  • Thailand
      • Bangkok, Thailand, 10400
      • Bangkok, Thailand, 10700
      • Bangkok, Thailand, 10330
  • United Kingdom
      • London, United Kingdom, W12 0NN
    • Cheshire
      • Cheadle, Cheshire, United Kingdom, SK8 5LL
    • Middlesex
      • Northwood, Middlesex, United Kingdom, HA6 2RN
    • North Somerset
      • Weston-super-Mare, North Somerset, United Kingdom, BS23 4BP
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG2 4PJ
    • Stratchclyde
      • Glasgow, Stratchclyde, United Kingdom, G45 9AW

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Age between 18 and 50 years (inclusive) at visit 1, for smokers up to 35 years (inclusive)
  • Otherwise healthy female subjects requesting contraception and currently using a levonorgestrel, gestodene or desogestrel containing oral contraceptive in a 21-day regimen and suffering from at least moderate pelvic pain, headache or both defined by an average value of >/= 35 mm for the 3 highest values on a visual analogue scale during cycle days 22-28.
  • Normal or clinically insignificant cervical smear not requiring further follow up (or a normal result obtained within the last 6 months before screening)
  • Able to tolerate ibuprofen and willing to use only ibuprofen supplied for the study.

Exclusion Criteria:

  • Women with any contraindication for oral contraceptive use

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm 2
Drug: Encapsulated Microgynon + Placebo
Day 1 to 21; 0.03 mg ethinylestradiol (EE) + 0.15 mg levonorgestrel (LNG). Day 22 to 28 placebo
Experimental: Arm 1
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To compare SH T00658ID (Qlaira) to Microgynon with regard to changes in frequency and intensity of the hormone withdrawal associated symptoms headache and pelvic pain on cycle days 22-28 combined into a single endpoint
Time Frame: Baseline to cycle 6
Baseline to cycle 6

Secondary Outcome Measures

Outcome Measure
Time Frame
Rescue medication consumption
Time Frame: Baseline to cycle 6
Baseline to cycle 6
Frequency and intensity of other hormone-related symptoms (bloating or swelling, breast tenderness, and nausea or vomiting) during cycle days 22 to 28
Time Frame: Baseline to cycle 6
Baseline to cycle 6
Prevalence of individual hormone-related symptoms during cycle days 1 to 21
Time Frame: Baseline to cycle 6
Baseline to cycle 6
Prevalence of individual hormone-related symptoms during hormone-free interval, i.e. cycle days 27+28 for EV/DNG capsules and cycle days 22 to 28 for the comparator
Time Frame: Baseline, cycle 3 and cycle 6
Baseline, cycle 3 and cycle 6
Change in the average of the 3 highest VAS values of the hormone withdrawal associated symptoms pelvic pain or headache during cycle days 22 to 28 from baseline to cycle 3
Time Frame: Baseline to cycle 3
Baseline to cycle 3
Bleeding pattern and cycle control
Time Frame: Throughout
Throughout
QoL Questionnaires: Psychological General Well-Being Index (PGWBI), Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) and Clinical Global Index (CGI)
Time Frame: Baseline, cycle 2 and cycle 5
Baseline, cycle 2 and cycle 5
AEs and SAEs. Concomitant medication. Vital signs (heart rate and blood pressure). Body weight
Time Frame: Throughout
Throughout
General physical and gynecological examination
Time Frame: Screening and Final Visit
Screening and Final Visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

October 22, 2008

First Submitted That Met QC Criteria

October 22, 2008

First Posted (Estimate)

October 23, 2008

Study Record Updates

Last Update Posted (Estimate)

January 14, 2016

Last Update Submitted That Met QC Criteria

January 13, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 91550
  • 310787 (Other Identifier: Company Internal)
  • 2008-003226-42 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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