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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00778609
First received: October 22, 2008
Last updated: February 11, 2013
Last verified: February 2013
History of Changes
  Purpose

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).


Condition Intervention Phase
Oral Contraceptive
Headache
Pelvic Pain
 Drug: EV/DNG (Qlaira, BAY86-5027)
Drug: Encapsulated Microgynon + Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rescue medication consumption [ Time Frame: Baseline to cycle 6 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Prevalence of individual hormone-related symptoms during cycle days 1 to 21 [ Time Frame: Baseline to cycle 6 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Bleeding pattern and cycle control [ Time Frame: Throughout ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • AEs and SAEs. Concomitant medication. Vital signs (heart rate and blood pressure). Body weight [ Time Frame: Throughout ] [ Designated as safety issue: Yes ]
  • General physical and gynecological examination [ Time Frame: Screening and Final Visit ] [ Designated as safety issue: Yes ]

Enrollment: 452
Study Start Date: December 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00778609

  Show 64 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site
Click here to find results for studies related to Bayer Healthcare products.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Therapeutic Area Head, Bayer HealthCare AG
ClinicalTrials.gov Identifier: NCT00778609     History of Changes
Other Study ID Numbers: 91550, 310787, 2008-003226-42
Study First Received: October 22, 2008
Last Updated: February 11, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Mexico: Federal Commission for Protection Against Health Risks
Spain: Spanish Agency of Medicines
Switzerland: Swissmedic
Thailand: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Bayer:
Combined Oral Contraceptives
Pelvic Pain
Headache

Additional relevant MeSH terms:
Headache
Pelvic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Contraceptive Agents
Ethinyl Estradiol-Norgestrel Combination
Ethinyl estradiol, levonorgestrel drug combination
Contraceptives, Oral
 Contraceptives, Oral, Combined
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital

ClinicalTrials.gov processed this record on May 16, 2013