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

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ClinicalTrials.gov Identifier: NCT01638910
Recruitment Status : Completed
First Posted : July 12, 2012
Last Update Posted : December 17, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

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

Condition or disease Intervention/treatment Phase
Contraception Drug: EV/DNG (Qlaira, BAY86-5027) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 955 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : June 2012
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014


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)




Primary Outcome Measures :
  1. Number of unintended pregnancies [ Time Frame: Up to Cycle 13 (1 Cycle = 28 days) ]

Secondary Outcome Measures :
  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) ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01638910


  Show 39 Study Locations
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01638910     History of Changes
Other Study ID Numbers: 91773
First Posted: July 12, 2012    Key Record Dates
Last Update Posted: December 17, 2014
Last Verified: December 2014
Keywords provided by Bayer:
Efficacy
Safety
oral contraception
estradiol valerate
dienogest
Additional relevant MeSH terms:
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Dienogest
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Contraceptive Agents
Contraceptives, Oral
Estradiol
Polyestradiol phosphate
Nandrolone
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptive Agents, Male
Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Androgens
Anabolic Agents