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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Oral Contraceptive, Headache, Pelvic Pain

Intervention / Treatment
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* Drug: EV/DNG (Qlaira, BAY86-5027)
* Drug: Encapsulated Microgynon + Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: EV/DNG (Qlaira, BAY86-5027)<br>* 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<br>|
| Active Comparator: Arm 2<br> | Drug: Encapsulated Microgynon + Placebo<br>* Day 1 to 21; 0.03 mg ethinylestradiol (EE) + 0.15 mg levonorgestrel (LNG). Day 22 to 28 placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |  | Baseline to cycle 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Combined Oral Contraceptives, Pelvic Pain, Headache