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NCT01202123 Clinical Trial

Post Marketing Surveillance of MENOPUR

Infertility Clinical Trial

Official title:
Post Marketing Surveillance of MENOPUR

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01202123
Other study ID # FE999906 CS10
Secondary ID
Status Completed
Phase N/A
First received September 3, 2010
Last updated February 20, 2014
Start date December 2008
Est. completion date February 2014

Study information
Verified date February 2014
Source Ferring Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 2501
Est. completion date February 2014
Est. primary completion date November 2013
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Seoul´s Women´s Hospital Bucheon Gyeonggi Province
Korea, Republic of Busan Maria hospital Busan
Korea, Republic of Daegu Maria Daegu
Korea, Republic of Daejeon Maria Daejeon
Korea, Republic of Daejeon Seoul Women Hospital Daejeon
Korea, Republic of Ellemedi Women Clinic Daejeon
Korea, Republic of Miz Women's Hospital Daejeon Daejeon Metropolitan City
Korea, Republic of Gumi CHA University Medical Center Gumi Kyoungbuk Province
Korea, Republic of Ilsan Maria Hospital Ilsan Gyeonggi Province
Korea, Republic of Incheon Seoul women Hospital Incheon
Korea, Republic of Premedi Women's Clinic Kwangju Kwangju Metropolitan City
Korea, Republic of Cheil General Hospital & Women's Healthcare Center Seoul
Korea, Republic of Gangseo Mizmedi Hospital Seoul
Korea, Republic of Hamchoon women clinic Seoul
Korea, Republic of Maria Hospital Seoul ´Shinseoul-dong, Dongdaemun-gu
Korea, Republic of Maria Plus Hospital Seoul
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of Songnae Maria Hospital Seoul
Korea, Republic of Mama Papa & Baby Hospital Ulsan Kyoungnam Province

Sponsors (1)
Lead Sponsor Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of follicles per cycle An ART cycle: From ovulation (number and size) to when chemical pregnancy test results are recorded Up to 6 weeks No
Secondary Number of adverse events An ART cycle: From ovulation (number and size) to when chemical pregnancy test results are recorded Up to 6 weeks Yes
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