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Trial record 13 of 27 for:    DROSPIRENONE AND ETHINYL ESTRADIOL AND bleeding

YAZ Post Authorization Safety Study (PASS)/Post Authorization Efficacy Study (PAES) in China

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ClinicalTrials.gov Identifier: NCT02710708
Recruitment Status : Completed
First Posted : March 17, 2016
Last Update Posted : June 28, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE March 14, 2016
First Posted Date  ICMJE March 17, 2016
Last Update Posted Date June 28, 2019
Actual Study Start Date  ICMJE May 27, 2016
Actual Primary Completion Date July 3, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 14, 2016)
Number of subjects with adverse drug reactions (ADRs) [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02710708 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2019)
  • Number of unintended pregnancies as measured by the Pearl Index (PI) [ Time Frame: 6 months ]
  • Cycle control for subjects with and without proceeding abortion [ Time Frame: 6 months ]
  • Number of bleeding days [ Time Frame: Up to 90 days. ]
  • Number of bleeding episodes [ Time Frame: Up to 90 days. ]
  • Number of Acne lesions [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2016)
  • Number of unintended pregnancies as measured by the Pearl Index (PI) [ Time Frame: 6 months ]
  • Number of bleeding days [ Time Frame: Up to 90 days. ]
  • Number of bleeding episodes [ Time Frame: Up to 90 days. ]
  • Number of Acne lesions [ Time Frame: 6 months ]
  • Severity of pain during menstruation measured by visual analog scale (VAS) [ Time Frame: 6 months ]
Current Other Pre-specified Outcome Measures
 (submitted: March 12, 2019)
Severity of pain during menstruation measured by visual analog scale (VAS) [ Time Frame: 6 months ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE YAZ Post Authorization Safety Study (PASS)/Post Authorization Efficacy Study (PAES) in China
Official Title  ICMJE Single-arm, Open-label, Interventional Study to Observe the Safety and Efficacy Profile of the Combined Oral Contraceptive YAZ®, a 24-day Cyclic Regimen Containing Drospirenone 3 mg and Ethinyl Estradiol 20 µg During a Treatment Duration of 6 Cycles: a Post-authorization Safety and Efficacy Study in Chinese Women
Brief Summary

The primary objective is to assess the safety profile of YAZ in Chinese women, including adverse drug reactions (ADRs).

The secondary objectives are to investigate the rate of unintended pregnancies, the cycle control for subjects with and without preceding abortion, the bleeding pattern of subjects with and without preceding abortion (including the abortion-related bleeding pattern) and the efficacy in moderate acne vulgaris.

Another objective is to investigate the effect on dysmenorrhea.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Contraception
Intervention  ICMJE Drug: EE20/DRSP (YAZ, BAY86-5300)
YAZ (DRSP 3 mg/EE 20 µg), oral route, 6 cycles of 28 days per cycle, each cycle comprising 24 days of active tablets followed by 4 days of placebo tablets
Study Arms  ICMJE Experimental: Ethinyl Estradiol 20 (EE20)/DRSP (YAZ, BAY86-5300)
Chinese women between 18 and 45 years old inclusive (smokers not older than 35 years old) requesting oral contraception who have no contraindication to YAZ will be recruited for the study. Women who underwent surgical or medical abortions will also be recruited.
Intervention: Drug: EE20/DRSP (YAZ, BAY86-5300)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 12, 2019)
1921
Original Estimated Enrollment  ICMJE
 (submitted: March 14, 2016)
2000
Actual Study Completion Date  ICMJE July 3, 2018
Actual Primary Completion Date July 3, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Signed and dated informed consent
  • Chinese female subjects requesting oral contraception, including subjects who underwent abortion (medical or surgical)
  • Planned use of combined oral contraceptives for at least 6 cycles
  • Age: 18 to 45 years (inclusive); smokers must not be older than 35 years at the time of informed consent
  • At least 4 weeks postpartum for women who are not breastfeeding or after a second trimester abortion

Exclusion Criteria:

  • Evidence or suspicion of incomplete abortion (medical abortion subjects must have complete abortion confirmed by ultrasound [endometrial thickness ≤ 15 mm]).
  • Pregnancy or lactation
  • Menstrual disorders consistent with ovarian failure (eg, oligomenorrhea, amenorrhea, hypomenorrhea)
  • Abuse of alcohol, drugs, or medicine (eg, laxatives)
  • Inability to cooperate with the study procedures for any reason (eg, language comprehension, psychiatric illness, inability to get to the study site).
  • Any diseases or conditions that can compromise the function of body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study medication
  • Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
  • Any contraindication to YAZ according to the Chinese label, such as:

    • Renal impairment
    • Adrenal insufficiency
    • A high risk of arterial or venous thromboembolic diseases. Examples include subjects who are known to:

      • Have deep vein thrombosis or pulmonary embolism, now or in the past
      • Have cerebrovascular disease
      • Have coronary artery disease
      • Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (eg, subacute bacterial endocarditis with valvular disease, or atrial fibrillation)
      • Have inherited or acquired hypercoagulopathies
      • Have uncontrolled hypertension
      • Have diabetes mellitus with vascular disease
      • Have headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35
    • Breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past
    • Liver tumors, benign or malignant, or liver disease
  • Hypersensitivity to any ingredient of the study drug
  • Undiagnosed abnormal genital bleeding
  • Sterilized subjects or concomitant use of other hormonal contraception, intrauterine device (IUD), or intrauterine system (IUS) during the study
  • For subjects qualifying for the moderate acne subgroup:

    • Subjects with acne and atopy, comedonal acne or acne conglobata, sandpaper acne or acne with multiple large nodes, cysts, fistular comedones, or abscessing fistular ducts
    • Use of preparations that have an acne-inducing effect (eg, iodinated or bromated drugs, tuberculostatics, lithium, vitamin B1 [>1.5 mg daily], B6 [>2 mg daily], B12 [>6 µg daily], corticoids, adrenocorticotropic hormone anabolics, quinine, disulfiram, methoxypsoralene, phenobarbital, phenytoin, trimethadione, thyroid depressants, and certain oily cosmetics)
    • Subjects undergoing systemic acne treatment
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02710708
Other Study ID Numbers  ICMJE 18261
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP