Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

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.


Condition or disease Intervention/treatment Phase
Contraception Drug: EE20/DRSP (YAZ, BAY86-5300) Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1921 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 27, 2016
Actual Primary Completion Date : July 3, 2018
Actual Study Completion Date : July 3, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Arm Intervention/treatment
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.
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




Primary Outcome Measures :
  1. Number of subjects with adverse drug reactions (ADRs) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Number of unintended pregnancies as measured by the Pearl Index (PI) [ Time Frame: 6 months ]
  2. Cycle control for subjects with and without proceeding abortion [ Time Frame: 6 months ]
  3. Number of bleeding days [ Time Frame: Up to 90 days. ]
  4. Number of bleeding episodes [ Time Frame: Up to 90 days. ]
  5. Number of Acne lesions [ Time Frame: 6 months ]

Other Outcome Measures:
  1. Severity of pain during menstruation measured by visual analog scale (VAS) [ Time Frame: 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02710708


  Show 38 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Layout table for investigator information
Study Director: Bayer Study Director Bayer

Additional Information:
Layout table for additonal information
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02710708     History of Changes
Other Study ID Numbers: 18261
First Posted: March 17, 2016    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: June 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bayer:
birth control,
contraceptives safety,
contraceptives efficacy,
moderate acne vulgaris

Additional relevant MeSH terms:
Layout table for MeSH terms
Estradiol
Ethinyl Estradiol
Contraceptive Agents
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Reproductive Control Agents