Post Marketing Surveillance of MENOPUR

NCT ID: NCT01202123

Last Updated: 2014-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2501 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-12-31

Study Completion Date

2014-02-28

Brief Summary

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The purpose of this study is to evaluate the safety and efficacy of highly purified (HP) menotrophine to Korean women.

Detailed Description

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Conditions

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Infertility

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Anovulation in women (WHO group II)
* Controlled ovarian hyperstimulation cases for ART

Exclusion Criteria

* Hypersensitivity to MENOPUR
* Pregnancy, lactation or contraindication to pregnancy
* Ovarian cysts not related to polycystic ovarian syndrome
* Abnormal uterine bleeding
* Tumors in uterus, ovaries and breasts
* Ovarian hyperstimulation syndrome
* Thromboembolism or history of it
* Infertile due to other reason than anovulation
* High FSH level indication primary ovarian failure
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ferring Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Development Support

Role: STUDY_DIRECTOR

Ferring Pharmaceuticals

Locations

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Busan Maria hospital

Busan, Busan, South Korea

Site Status

Daegu Maria

Daegu, Daegu, South Korea

Site Status

Daejeon Maria

Daejeon, Daejeon, South Korea

Site Status

Daejeon Seoul Women Hospital

Daejeon, Daejeon, South Korea

Site Status

Ellemedi Women Clinic

Daejeon, Daejeon, South Korea

Site Status

Miz Women's Hospital

Daejeon, Daejeon Metropolitan City, South Korea

Site Status

Seoul´s Women´s Hospital

Bucheon-si, Gyeonggi Province, South Korea

Site Status

Ilsan Maria Hospital

Ilsan, Gyeonggi Province, South Korea

Site Status

Incheon Seoul women Hospital

Incheon, Incheon, South Korea

Site Status

Premedi Women's Clinic

Kwangju, Kwangju Metropolitan City, South Korea

Site Status

Gumi CHA University Medical Center

Gumi, Kyoungbuk Province, South Korea

Site Status

Mama Papa & Baby Hospital

Ulsan, Kyoungnam Province, South Korea

Site Status

Cheil General Hospital & Women's Healthcare Center

Seoul, Seoul, South Korea

Site Status

Gangseo Mizmedi Hospital

Seoul, Seoul, South Korea

Site Status

Hamchoon women clinic

Seoul, Seoul, South Korea

Site Status

Maria Plus Hospital

Seoul, Seoul, South Korea

Site Status

Samsung Medical Center

Seoul, Seoul, South Korea

Site Status

Songnae Maria Hospital

Seoul, Seoul, South Korea

Site Status

Maria Hospital

Seoul, ´Shinseoul-dong, Dongdaemun-gu, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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FE999906 CS10

Identifier Type: -

Identifier Source: org_study_id

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