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

Phase 4

Completed

• Conditions: Contraception
• Interventions: Drug: EE20/DRSP (YAZ, BAY86-5300)

• Registration Number: NCT02710708
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-14
• Study First Submitted QC: 2016-03-14
• Study First Posted: 2016-03-17
• Study Start: 2016-05-27
• Primary Completion: 2018-07-03
• Study Completion: 2018-07-03
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-27
• Last Update Posted: 2019-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1921

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ethinyl Estradiol 20 (EE20)/DRSP (YAZ, BAY86-5300)	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.

Primary Outcome Measures

Name	Time	Method
Number of subjects with adverse drug reactions (ADRs)	6 months

Secondary Outcome Measures

Name	Time	Method
Cycle control for subjects with and without proceeding abortion	6 months
Number of unintended pregnancies as measured by the Pearl Index (PI)	6 months
Number of Acne lesions	6 months
Number of bleeding days	Up to 90 days.
Number of bleeding episodes	Up to 90 days.