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OpenTrials
Completed

NCT Number: NCT01638910

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

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

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Key information

Conditions

Contraception

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Guangzhou, Guangdong, China

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EV/DNG (Qlaira, BAY86-5027)

Drug

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)

Primary outcomes

  1. Number of unintended pregnancies

    Time frame: Up to Cycle 13 (1 Cycle = 28 days)

Secondary outcomes

  1. Number of expected bleeding days

    Time frame: Up to Cycle 13 (1 Cycle = 28 days)

  2. Number of unexpected bleeding days

    Time frame: Up to Cycle 13 (1 Cycle = 28 days)

  3. Number of expected bleeding episodes

    Time frame: Up to Cycle 13 (1 Cycle = 28 days)

  4. Number of unexpected bleeding episodes

    Time frame: Up to Cycle 13 (1 Cycle = 28 days)

  5. Number of participants with Adverse Events as a Measure of Safety and Tolerability

    Time frame: Up to Cycle 13 (1 Cycle = 28 days)

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jul 12, 2012
Registry last updated
Dec 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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