Clinical trial NCT01638910: Efficacy and Safety of a Combined Oral Contraceptive of Estradiol Valerate and Dienogest in Healthy Female Subjects
Official title: A Multi-center, Open, Uncontrolled Phase 3 Study to Investigate the Efficacy and Safety of a 4-phasic Oral Contraceptive SH T00658ID Containing Estradiol Valerate and Dienogest in a 28-day Regimen for 13 Cycles in Healthy Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Contraception
Keywords: Efficacy
Safety
oral contraception
estradiol valerate
dienogest
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2012-07-12
Enrollment: 955
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To evaluate the efficacy and safety of a combined oral contraceptive of estradiol valerate and dienogest in healthy female subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy women between 18 and 50 for the entire study, except women enrolled from India should be aged between 18 and 40 years, requesting contraception
* Smokers may not exceed 35 years of age

Exclusion Criteria:

* Pregnancy or lactation (delivery, abortion, or lactation within less than three cycles before the start of treatment)
* Body mass index (BMI) \> 32 kg/m2
* Any disease or condition that may worsen under hormonal treatment
* Undiagnosed abnormal genital bleeding
* Other contraceptive methods such as sterilization, hormonal contraception, IUD within 30 days of Visit 1, monthly contraceptive injection within a period of three times of the injection interval before start of treatment
* Any medication that could result in excessive accumulation, impaired metabolism, or altered excretion of the study drug or interfere with the conduct of the study or the interpretation of the results

Primary outcomes:
measure: Number of unintended pregnancies
timeFrame: Up to Cycle 13 (1 Cycle = 28 days)
Secondary outcomes:
measure: Number of expected bleeding days
timeFrame: Up to Cycle 13 (1 Cycle = 28 days)
measure: Number of unexpected bleeding days
timeFrame: Up to Cycle 13 (1 Cycle = 28 days)
measure: Number of expected bleeding episodes
timeFrame: Up to Cycle 13 (1 Cycle = 28 days)
measure: Number of unexpected bleeding episodes
timeFrame: Up to Cycle 13 (1 Cycle = 28 days)
measure: Number of participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: Up to Cycle 13 (1 Cycle = 28 days)
Other outcomes:
Locations:
city: Guangzhou,
country: China
state: Guangdong
city: Guangzhou
country: China
state: Guangdong
city: Shijiazhuang
country: China
state: Hebei
city: Wuhan
country: China
state: Hubei
city: Wuhan
country: China
state: Hubei
city: Changsha
country: China
state: Hunan
city: Hengyang
country: China
state: Hunan
city: Nanjing
country: China
state: Jiangsu
city: Dalian
country: China
state: Liaoning
city: Shenyang
country: China
state: Liaoning
city: Jinan
country: China
state: Shandong
city: Chengdu
country: China
state: Sichuan
city: Wenzhou
country: China
state: Zhejiang
city: Beijing
country: China
city: Beijing
country: China
city: Chongqing
country: China
city: Chongqing
country: China
city: Chongqing
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Tianjin
country: China
city: Hongkong
country: Hong Kong
city: Pune
country: India
state: Maharashtra
city: Chandigarh
country: India
city: Karnal
country: India
city: New Delhi
country: India
city: Pune
country: India
city: Secunderabad
country: India
city: Kaohsiung
country: Taiwan
city: Taichung
country: Taiwan
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
city: Taoyuan
country: Taiwan
city: Bangkok
country: Thailand
city: Bangkok
country: Thailand
city: Chiangmai
country: Thailand
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Yu Q, Huang Z, Ren M, Chang Q, Zhang Z, Parke S. Contraceptive efficacy and safety of estradiol valerate/dienogest in a healthy female population: a multicenter, open-label, uncontrolled Phase III study. Int J Womens Health. 2018 Jun 7;10:257-266. doi: 10.2147/IJWH.S157056. eCollection 2018.