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

Contraception Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02710708
• Other study ID #: 18261
• Status: Completed
• Phase: Phase 4
• Start date: May 27, 2016
• Est. completion date: July 3, 2018

Study information

• Verified date: June 2019
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1921
• Est. completion date: July 3, 2018
• Est. primary completion date: July 3, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Severity of pain during menstruation measured by visual analog scale (VAS)		6 months
Primary	Number of subjects with adverse drug reactions (ADRs)		6 months
Secondary	Number of unintended pregnancies as measured by the Pearl Index (PI)		6 months
Secondary	Cycle control for subjects with and without proceeding abortion		6 months
Secondary	Number of bleeding days		Up to 90 days.
Secondary	Number of bleeding episodes		Up to 90 days.
Secondary	Number of Acne lesions		6 months

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