Who is sponsoring NCT00778609?

NCT00778609 is sponsored by Bayer.

What condition does NCT00778609 study?

NCT00778609 studies Oral Contraceptive, Headache, Pelvic Pain.

What drugs are being tested in NCT00778609?

Interventions: EV/DNG (Qlaira, BAY86-5027), Encapsulated Microgynon + Placebo.

What is the status of NCT00778609?

NCT00778609 is currently COMPLETED.

Last reviewed 2016-01-13 · How we verify

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

NCT00778609 Phase 3 COMPLETED

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).

Details

Lead sponsor	Bayer
Phase	Phase 3
Status	COMPLETED
Enrolment	449
Start date	2008-12
Completion	2010-12

Conditions

Oral Contraceptive
Headache
Pelvic Pain

Interventions

EV/DNG (Qlaira, BAY86-5027)
Encapsulated Microgynon + Placebo

Primary outcomes

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

Countries

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