Qlaira Post-authorization Safety Study Related to Most Common Adverse Events in Mexican Women Who Wish to Avoid Pregnancy

CompletedOBSERVATIONAL
Enrollment

1

Participants

Timeline

Start Date

February 6, 2015

Primary Completion Date

May 17, 2017

Study Completion Date

October 31, 2017

Conditions
Contraception
Interventions
DRUG

EV/DNG (Qlaira, BAY86-5027)

Qlaira is taken daily continously with no pause between cycles in a four-phasic dose regimen, making up a treatment of up to 28 days. The first two tablets contain 3 mg Estradiol Valerate (E2V). The next five tablets include 2 mg E2V and 2 mg Dienogest (DNG) followed by 17 tablets with 2 mg E2V and 3 mg DNG. Finally, there are two tablets with 1 mg E2V and two placebo tablets.

Trial Locations (1)

Unknown

Multiple Locations

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY

NCT01602770 - Qlaira Post-authorization Safety Study Related to Most Common Adverse Events in Mexican Women Who Wish to Avoid Pregnancy | Biotech Hunter | Biotech Hunter