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

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00778609

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, SH T00658ID) Drug: Encapsulated Microgynon + Placebo	Phase III

MedlinePlus related topics: Headache Nausea and Vomiting Pelvic Pain

Drug Information available for: Depogen Estradiol Estradiol 3-benzoate Estradiol acetate Estradiol cypionate Estradiol dipropionate Estradiol valerate Polyestradiol phosphate Ethinyl estradiol Levonorgestrel Ethinyl estradiol-norgestrel combination Dienogest

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study
Official Title:	A Multicenter, Randomized, Double-Blind, Active-Controlled, Parallel Group, 2-Arm Study to Investigate the Effect of Estradiol Valerate/Dienogest Compared to Microgynon on Hormone Withdrawal Associated Symptoms in Healthy Women After 6 Cycles

Further study details as provided by Bayer:

Primary Outcome Measures:

To compare SH T00658ID 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. [ 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 VAS 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 ]

Estimated Enrollment:	880
Study Start Date:	December 2008
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental	Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658ID) 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
Arm 2: Active Comparator	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 30 years (inclusive)
Otherwise healthy female subjects requesting contraception and currently using a levonorgestrel 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 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

Contacts

Contact: Bayer Clinical Trials Contact

clinical-trials-contact@bayerhealthcare.com

Show 49 Study Locations

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

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Responsible Party:	Bayer Schering Pharma AG ( Therapeutic Area Head )
Study ID Numbers:	91550, EudraCT: 2008-003226-42, 310787
Study First Received:	October 22, 2008
Last Updated:	December 18, 2008
ClinicalTrials.gov Identifier:	NCT00778609
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration; Finland: National Agency for Medicines; France: Afssaps - French Health Products Safety Agency; 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; United States: Food and Drug Administration

Keywords provided by Bayer:

Combined Oral Contraceptives
Pelvic Pain
Headache

Study placed in the following topic categories:

Estradiol valerate
Ethinyl Estradiol
Pain
Healthy
Estradiol 17 beta-cypionate
Estradiol
Norgestrel
Signs and Symptoms

Pelvic Pain
Estradiol 3-benzoate
Levonorgestrel
Headache
Neurologic Manifestations
Ethinyl Estradiol-Norgestrel Combination
Polyestradiol phosphate
Dienogest

Additional relevant MeSH terms:

Contraceptives, Oral, Combined
Contraceptives, Postcoital, Synthetic
Contraceptive Agents
Therapeutic Uses
Contraceptives, Oral
Physiological Effects of Drugs

Nervous System Diseases
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Reproductive Control Agents
Contraceptives, Postcoital
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009