NCT00998257

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
770

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2009

Completed
29 days until next milestone

First Posted

Study publicly available on registry

October 20, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

January 21, 2015

Status Verified

January 1, 2015

Enrollment Period

2.3 years

First QC Date

September 21, 2009

Last Update Submit

January 19, 2015

Conditions

ContraceptionPremenstrual SyndromeAcne

Keywords

ContraceptionPremenstrual Dysphoric DisorderPMDDAcne

Outcome Measures

Primary Outcomes (4)

  • Adverse event collection

    After taking YAZ for 3 cycles and 6 cycles (1 cycle is 28 days)

  • Contraception efficacy

    After taking YAZ for 3 cycles and 6 cycles (1 cycle is 28 days)

  • Drug compliance

    After taking YAZ for 3 cycles and 6 cycles (1 cycle is 28 days)

  • Release of Premenstrual Dysphoric Disorder (PMDD) or acne

    After taking YAZ for 3 cycles and 6 cycles (1 cycle is 28 days)

Secondary Outcomes (3)

  • Number of patients who used YAZ just for contraception

    At initial visit (Day 0)

  • Number of patients who used YAZ for PMDD + contraception

    At initial visit (Day 0)

  • Number of patients who used YAZ for Acne + contraception

    At initial visit (Day 0)

Study Arms (1)

Group 1

Drug: EE20/DRSP (YAZ, BAY86-5300)

Interventions

EE20/DRSP (YAZ, BAY86-5300)DRUG

Patients under daily life treatment with YAZ according to local drug information.

Group 1

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Korean female who need only contraception or contraception and management of PMDD or contraception and treatment of acne.

You may qualify if:

  • Healthy female subjects
  • requesting contraception
  • suggesting PMDD by Physician who are also requesting contraception
  • with acne who are also requesting contraception
  • Age: 18 - 50 years
  • Women who is prescribed YAZ first, during study period

You may not qualify if:

  • Women who are contraindicated based on the label of YAZ
  • Presence or a history of venous or arterial thrombotic/ thromboembolic events (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident
  • Presence or history of prodromi of a thrombosis (e.g. transient ischaemic attack, angina pectoris)
  • History of migraine with focal neurological symptoms
  • Diabetes mellitus with vascular involvement
  • The presence of a severe or multiple risk factor(s) for venous or arterial thrombosis may also constitute a contraindication
  • Pancreatitis or a history thereof if associated with severe hypertriglyceridemia
  • Presence or history of severe hepatic disease as long as liver function values have not returned to normal
  • Severe renal insufficiency or acute renal failure
  • Presence or history of liver tumours (benign or malignant)
  • Known or suspected sex-steroid influenced malignancies (e.g. of the genital organs or the breasts)
  • Undiagnosed vaginal bleeding
  • Known or suspected pregnancy
  • Hypersensitivity to the active substances or to any of the excipients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Many Locations, South Korea

Location

MeSH Terms

Conditions

Premenstrual SyndromeAcne VulgarisPremenstrual Dysphoric Disorder

Interventions

drospirenone and ethinyl estradiol combination

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsAcneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland DiseasesDepressive DisorderMood DisordersMental Disorders

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2009

First Posted

October 20, 2009

Study Start

July 1, 2009

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

January 21, 2015

Record last verified: 2015-01

Locations

KR(1)