NCT01602770 is a clinical trial of EV/DNG (Qlaira, BAY86-5027) in Contraception, sponsored by Bayer.

Who is sponsoring NCT01602770?

NCT01602770 is sponsored by Bayer.

What drugs are being tested in NCT01602770?

Interventions in NCT01602770: EV/DNG (Qlaira, BAY86-5027).

What condition does NCT01602770 study?

NCT01602770 studies Contraception.

Is NCT01602770 still recruiting?

NCT01602770 is currently completed. Last updated 29 April 2019.

Last reviewed 2019-04-29 · How we verify

NCT01602770

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Last updated 29 April 2019

What this trial tests

trial testing EV/DNG (Qlaira, BAY86-5027) in Contraception in 1 participant. Completed in 31 October 2017.

Timeline

6 February 2015

Primary endpoint
17 May 2017

31 October 2017

Quick facts

Lead sponsor	Bayer
Status	Completed
Study type	OBSERVATIONAL
Enrollment	1
Start date	6 February 2015
Primary completion	17 May 2017
Estimated completion	31 October 2017
Sites	1 location across Mexico

Drugs / interventions tested

EV/DNG (Qlaira, BAY86-5027) — full drug profile →

Conditions studied

Contraception — all drugs for Contraception →

Sponsor

Bayer — full company profile →

Who can join

Adults 18 to 40, female only, with Contraception. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Qlaira is a combined oral contraceptive (COC) containing dienogest/estradiol valerate being the first oral contraceptive delivering estradiol. It has been recently approved in Mexico. To evaluate the clinical profile of this drug combination under routine medical condition, a post-authorization safety study required by Mexican Health Authorities will be conducted in Mexican women. The study will be performed as a descriptive study, no hypothesis will be tested. The cohort consists of 300 new users (first-ever users or switchers) of Qlaira under routine medical conditions. Subjects should provide all necessary information on health-related events or changes in health status during Qlaira use. Primary variable will be the incidence of Adverse Events (AE) at any time point, whether or not related to Qlaira during at least 2 years of observation. In order to comply with the criteria of a non-interventional study, women only will be informed about the study, asked to participate and included in the study after Qlaira has been prescribed. Study patients follow-up will be done in accordance with common clinical practice as described at Mexican Official Guidelines for prescription of Family Planning Methods (NOM 005-SSA2-1993).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of EV/DNG (Qlaira, BAY86-5027)

Trials testing the same drug.

NCT01797809 — Qlaira rPMS (Regulatory Post Marketing Surveillance) Study in Korea · completed

Other recruiting trials for Contraception

Currently open trials in the same condition.

NCT07365904 — Investigating Ovulation Inhibition for Use as a Contraceptive · Phase 2 · recruiting
NCT07437495 — Women's Knowledge of Contraception During the Postpartum Period · active not recruiting
NCT06823037 — Hormonal Contraception Access Through Pharmacist Prescribing Implementation · NA · recruiting
NCT07326007 — Verbal Analgesia Versus Standard Technique for Pain Control During Copper T380A Intrauterine Device Insertion in Women W · NA · recruiting
NCT05910580 — Improving Alcohol and Substance Use Care Access, Outcome, Equity During the Reproductive Years · NA · recruiting

Other Bayer trials

Trials by the same sponsor.

NCT05900388 — A Study to Observe the Pattern of Use and Safety of Rivaroxaban in Children Under 2 Years Old With Venous Thromboembolis · not yet recruiting
NCT07490431 — An Observational Study to Learn More About How Elinzanetant is Used and How Well it Works for Women With Menopause Sympt · not yet recruiting
NCT05477953 — An Observational Pregnancy Safety Study in Women Who Were Exposed to the Drug Nifurtimox During Pregnancy to Learn About · not yet recruiting
NCT07192952 — A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Child · Phase 3 · not yet recruiting
NCT07450599 — A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Befo · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01602770 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bayer
Last refreshed: 29 April 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01602770.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing