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

Contraception Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01638910
• Other study ID #: 91773
• Status: Completed
• Phase: Phase 3
• First received: June 20, 2012
• Last updated: December 16, 2014
• Start date: June 2012
• Est. completion date: November 2014

Study information

• Verified date: December 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug AdministrationIndia: Drugs Controller General of IndiaTaiwan : Food and Drug AdministrationThailand: Food and Drug AdministrationHong Kong: Department of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 955
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Contraception

Intervention

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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

China,  Hong Kong,  India,  Taiwan,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of unintended pregnancies		Up to Cycle 13 (1 Cycle = 28 days)	No
Secondary	Number of expected bleeding days		Up to Cycle 13 (1 Cycle = 28 days)	No
Secondary	Number of unexpected bleeding days		Up to Cycle 13 (1 Cycle = 28 days)	No
Secondary	Number of expected bleeding episodes		Up to Cycle 13 (1 Cycle = 28 days)	No
Secondary	Number of unexpected bleeding episodes		Up to Cycle 13 (1 Cycle = 28 days)	No
Secondary	Number of participants with Adverse Events as a Measure of Safety and Tolerability		Up to Cycle 13 (1 Cycle = 28 days)	Yes

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