NCT00998257 is a clinical trial of EE20/DRSP (YAZ, BAY86-5300) in Contraception, sponsored by Bayer.

Who is sponsoring NCT00998257?

NCT00998257 is sponsored by Bayer.

What drugs are being tested in NCT00998257?

Interventions in NCT00998257: EE20/DRSP (YAZ, BAY86-5300).

What condition does NCT00998257 study?

NCT00998257 studies Contraception, Premenstrual Syndrome, Acne.

Is NCT00998257 still recruiting?

NCT00998257 is currently completed. Last updated 19 January 2015.

Last reviewed 2015-01-19 · How we verify

NCT00998257

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

Regulatory Post Marketing Surveillance Study on YAZ

Completed Last updated 19 January 2015

What this trial tests

trial testing EE20/DRSP (YAZ, BAY86-5300) in Contraception in 770 participants. Completed in 1 November 2011.

Timeline

1 July 2009

Primary endpoint
1 November 2011

1 November 2011

Quick facts

Lead sponsor	Bayer
Status	Completed
Study type	OBSERVATIONAL
Enrollment	770
Start date	1 July 2009
Primary completion	1 November 2011
Estimated completion	1 November 2011
Sites	1 location across South Korea

Drugs / interventions tested

EE20/DRSP (YAZ, BAY86-5300) — full drug profile →

Conditions studied

Contraception — all drugs for Contraception →
Premenstrual Syndrome — all drugs for Premenstrual Syndrome →
Acne — all drugs for Acne →

Sponsor

Bayer — full company profile →

Who can join

Adults 18 to 50, female only, with Contraception or Premenstrual Syndrome. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Adverse event collection
Time frame: After taking YAZ for 3 cycles and 6 cycles (1 cycle is 28 days)
Contraception efficacy
Time frame: After taking YAZ for 3 cycles and 6 cycles (1 cycle is 28 days)
Drug compliance
Time frame: After taking YAZ for 3 cycles and 6 cycles (1 cycle is 28 days)
Release of Premenstrual Dysphoric Disorder (PMDD) or acne
Time frame: After taking YAZ for 3 cycles and 6 cycles (1 cycle is 28 days)

Sponsor's own description

The objective of this Post Marketing Surveillance (PMS) is to gain information about safety and efficacy in real practice.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Efficacy and safety of a 24-day regimen of drospirenone-containing combined oral contraceptive in Korean women.
Kim N, Yoo HN, Hyun HS, Lee DY, et al · · 2015 · cited 5× · PMID 26430665 · DOI 10.5468/ogs.2015.58.5.397

Verify or expand the search:

Other trials of EE20/DRSP (YAZ, BAY86-5300)

Trials testing the same drug.

NCT02710708 — YAZ Post Authorization Safety Study (PASS)/Post Authorization Efficacy Study (PAES) in China · Phase 4 · 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 NCT00998257 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
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: 19 January 2015

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/NCT00998257.

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