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

Phase 3

Completed

• Conditions: Oral Contraceptive; Headache; Pelvic Pain
• Interventions: Drug: EV/DNG (Qlaira, BAY86-5027); Drug: Encapsulated Microgynon + Placebo

• Registration Number: NCT00778609
• Lead Sponsor: Bayer

Brief 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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2008-10-22
• Study First Submitted QC: 2008-10-22
• Study First Posted: 2008-10-23
• Study Start: 2008-12
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-13
• Last Update Posted: 2016-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 449

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.

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Exclusion Criteria

• Women with any contraindication for oral contraceptive use

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	EV/DNG (Qlaira, BAY86-5027)	-
Arm 2	Encapsulated Microgynon + Placebo	-

Primary Outcome Measures

Name	Time	Method
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	Baseline to cycle 6

Secondary Outcome Measures

Name	Time	Method
Rescue medication consumption	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	Baseline to cycle 6
Prevalence of individual hormone-related symptoms during cycle days 1 to 21	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	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	Baseline to cycle 3
Bleeding pattern and cycle control	Throughout
QoL Questionnaires: Psychological General Well-Being Index (PGWBI), Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) and Clinical Global Index (CGI)	Baseline, cycle 2 and cycle 5
AEs and SAEs. Concomitant medication. Vital signs (heart rate and blood pressure). Body weight	Throughout
General physical and gynecological examination	Screening and Final Visit