Efficacy and Safety of a Combined Oral Contraceptive of Estradiol Valerate and Dienogest in Healthy Female Subjects

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

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

Study Overview

• Status: Completed
• Conditions: Contraception
• Intervention / Treatment: Drug: EV/DNG (Qlaira, BAY86-5027)

• Study Type: Interventional
• Enrollment (Actual): 955
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100044
  • Beijing, China, 100730
  • Chongqing, China, 400038
  • Chongqing, China, 400042
  • Chongqing, China, 400016
  • Shanghai, China, 200127
  • Shanghai, China, 200025
  • Shanghai, China, 200030
  • Shanghai, China, 2100129
  • Tianjin, China, 300211
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
    • Guangzhou,, Guangdong, China, 510405
  • Hebei
    • Shijiazhuang, Hebei, China, 050051
  • Hubei
    • Wuhan, Hubei, China, 430032
    • Wuhan, Hubei, China, 430030
  • Hunan
    • Changsha, Hunan, China, 410013
    • Hengyang, Hunan, China, 421001
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
  • Liaoning
    • Dalian, Liaoning, China, 116011
    • Shenyang, Liaoning, China, 110004
  • Shandong
    • Jinan, Shandong, China, 250012
  • Sichuan
    • Chengdu, Sichuan, China, 610041
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325027
• Hong Kong
  • Hongkong, Hong Kong
• India
  • Chandigarh, India
  • Karnal, India, 132001
  • New Delhi, India, 110 029
  • Pune, India, 411004
  • Secunderabad, India, 500003
  • Maharashtra
    • Pune, Maharashtra, India, 411001
• Taiwan
  • Kaohsiung, Taiwan, 80756
  • Taichung, Taiwan, 40705
  • Taipei, Taiwan, 100
  • Taipei, Taiwan, 11217
  • Taipei, Taiwan, 116
  • Taoyuan, Taiwan, 333
• Thailand
  • Bangkok, Thailand, 10700
  • Bangkok, Thailand, 10330
  • Chiangmai, Thailand, 50200

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EV/DNG (Qlaira, BAY86-5027)	Drug: EV/DNG (Qlaira, BAY86-5027); Oral estradiol valerate and dienogest (2 days 3.0 mg estradiol valerate (EV), 5 days 2.0 mg EV + 2.0 mg dienogest (DNG), 17 days 2.0 mg EV + 3.0 mg DNG, 2 days 1.0 mg EV, 2 days placebo), one table oral daily for 13 treatment cycles (1 cycle = 28days)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of unintended pregnancies	Up to Cycle 13 (1 Cycle = 28 days)

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of expected bleeding days	Up to Cycle 13 (1 Cycle = 28 days)
Number of unexpected bleeding days	Up to Cycle 13 (1 Cycle = 28 days)
Number of expected bleeding episodes	Up to Cycle 13 (1 Cycle = 28 days)
Number of unexpected bleeding episodes	Up to Cycle 13 (1 Cycle = 28 days)
Number of participants with Adverse Events as a Measure of Safety and Tolerability	Up to Cycle 13 (1 Cycle = 28 days)

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: June 20, 2012
• First Submitted That Met QC Criteria: July 10, 2012
• First Posted (Estimate): July 12, 2012

Study Record Updates

• Last Update Posted (Estimate): December 17, 2014
• Last Update Submitted That Met QC Criteria: December 16, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Safety; Efficacy; oral contraception; dienogest; estradiol valerate
• Other Study ID Numbers: 91773