NCT00778609

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 449 (actual)
• Sponsor: Bayer · Industry
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Oral Contraceptive
• Headache
• Pelvic Pain

Interventions

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

Timeline

• Start date: 2008-12-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2008-10-23
• Last updated: 2016-01-14

Locations

63 sites across 9 countries: Australia, Finland, France, Germany, Mexico, Spain, Switzerland, Thailand, United Kingdom