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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00778609
Other study ID # 91550
Secondary ID 3107872008-00322
Status Completed
Phase Phase 3
First received October 22, 2008
Last updated January 13, 2016
Start date December 2008
Est. completion date December 2010

Study information

Verified date January 2016
Source Bayer
Contact n/a
Is FDA regulated No
Health authority Australia: Department of Health and Ageing Therapeutic Goods AdministrationFinland: Finnish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesMexico: Federal Commission for Protection Against Health RisksSpain: Spanish Agency of MedicinesSwitzerland: SwissmedicThailand: Food and Drug AdministrationUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 449
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 50 Years
Eligibility 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 Design

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


Related Conditions & MeSH terms


Intervention

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
Encapsulated Microgynon + Placebo
Day 1 to 21; 0.03 mg ethinylestradiol (EE) + 0.15 mg levonorgestrel (LNG). Day 22 to 28 placebo

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Bayer

Countries where clinical trial is conducted

Australia,  Finland,  France,  Germany,  Mexico,  Spain,  Switzerland,  Thailand,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Rescue medication consumption Baseline to cycle 6 No
Secondary 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 No
Secondary Prevalence of individual hormone-related symptoms during cycle days 1 to 21 Baseline to cycle 6 No
Secondary 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 No
Secondary 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 No
Secondary Bleeding pattern and cycle control Throughout No
Secondary 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 No
Secondary AEs and SAEs. Concomitant medication. Vital signs (heart rate and blood pressure). Body weight Throughout Yes
Secondary General physical and gynecological examination Screening and Final Visit Yes
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