Study of a 4-phasic Oral Contraceptive for the Treatment of Heavy Menstrual Bleeding

Last updated: July 8, 2015
Sponsor: Bayer
Overall Status: Completed

Phase

3

Condition

Menstrual Disorders

Female Hormonal Deficiencies/abnormalities

Hemorrhage

Treatment

N/A

Clinical Study ID

NCT01638923
91774
X311965
  • Ages > 18
  • Female

Study Summary

To evaluate efficacy and safety of a combined oral contraceptive of estradiol valerate and dienogest in the treatment of heavy menstrual bleeding

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Women 18 years or older in generally good health with a diagnosis of heavy menstrualbleeding without organic pathology, requesting contraception

  • Willingness to use barrier contraception (e.g., condoms) from screening to studycompletion

  • Willingness to use and collect sanitary protection (pads and tampons) provided by thesponsor and compatible with the alkaline hematin test throughout study completion

Exclusion

Exclusion Criteria:

  • Current diagnosis of organic uterine bleeding

  • History of endometrial ablation, or dilatation and curettage within 2 months of Visit

  • Clinically significant pelvic findings (whether or not confirmed by transvaginalultrasound [TVU]).

  • Clinically significant abnormal results of breast examination (breast palpation).

  • Positive pregnancy test at Visit 1

  • Less than three months since delivery, abortion, or lactation before to start Visit 1

  • Other contraceptive methods

  • Any disease or condition that may worsen under hormonal treatment

  • Smokers over the age of 35

  • Body mass index >32

Study Design

Total Participants: 339
Study Start date:
June 01, 2012
Estimated Completion Date:
June 30, 2015

Connect with a study center

  • Guangzhou, Guangdong 510120
    China

    Site Not Available

  • Nanning, Guangxi 530021
    China

    Site Not Available

  • Shijiazhuang, Hebei 050051
    China

    Site Not Available

  • Wuhan, Hubei 430030
    China

    Site Not Available

  • Changsha, Hunan 410013
    China

    Site Not Available

  • Hengyang, Hunan 421001
    China

    Site Not Available

  • Dalian, Liaoning 116011
    China

    Site Not Available

  • Shenyang, Liaoning 110004
    China

    Site Not Available

  • Xi'an, Shaanxi 710032
    China

    Site Not Available

  • Jinan, Shandong 250012
    China

    Site Not Available

  • Chengdu, Sichuan 610072
    China

    Site Not Available

  • Beijing, 100034
    China

    Site Not Available

  • Changchun,
    China

    Site Not Available

  • Chongqing, 400010
    China

    Site Not Available

  • Qingdao, 266071
    China

    Site Not Available

  • Shanghai, 200030
    China

    Site Not Available

  • Tianjin, 300211
    China

    Site Not Available

  • Manila,
    Philippines

    Site Not Available

  • Quezon City,
    Philippines

    Site Not Available

  • Irkutsk, 664003
    Russian Federation

    Site Not Available

  • Ivanovo, 153045
    Russian Federation

    Site Not Available

  • Krasnodar, 350012
    Russian Federation

    Site Not Available

  • Moscow, 117415
    Russian Federation

    Site Not Available

  • St. Petersburg, 194354
    Russian Federation

    Site Not Available

  • Singapore, 229899
    Singapore

    Site Not Available

  • Taichung, 40705
    Taiwan

    Site Not Available

  • Tainan,
    Taiwan

    Site Not Available

  • Taipei, 100
    Taiwan

    Site Not Available

  • Bangkok, 10700
    Thailand

    Site Not Available

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