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

Headache Clinical Trial

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

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

• Headache
• Oral Contraceptive
• Pelvic Pain

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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