Post Marketing Surveillance of MENOPUR

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01202123
First received: September 3, 2010
Last updated: February 20, 2014
Last verified: February 2014
  Purpose

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


Condition
Infertility

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Post Marketing Surveillance of MENOPUR

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Number of follicles per cycle [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: No ]
    An ART cycle: From ovulation (number and size) to when chemical pregnancy test results are recorded


Secondary Outcome Measures:
  • Number of adverse events [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: Yes ]
    An ART cycle: From ovulation (number and size) to when chemical pregnancy test results are recorded


Enrollment: 2501
Study Start Date: December 2008
Study Completion Date: February 2014
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Infertile women

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01202123

Locations
Korea, Republic of
Miz Women's Hospital
Daejeon, Daejeon Metropolitan City, Korea, Republic of
Seoul´s Women´s Hospital
Bucheon, Gyeonggi Province, Korea, Republic of
Ilsan Maria Hospital
Ilsan, Gyeonggi Province, Korea, Republic of
Premedi Women's Clinic
Kwangju, Kwangju Metropolitan City, Korea, Republic of
Gumi CHA University Medical Center
Gumi, Kyoungbuk Province, Korea, Republic of
Mama Papa & Baby Hospital
Ulsan, Kyoungnam Province, Korea, Republic of
Busan Maria hospital
Busan, Korea, Republic of
Daegu Maria
Daegu, Korea, Republic of
Ellemedi Women Clinic
Daejeon, Korea, Republic of
Daejeon Maria
Daejeon, Korea, Republic of
Daejeon Seoul Women Hospital
Daejeon, Korea, Republic of
Incheon Seoul women Hospital
Incheon, Korea, Republic of
Maria Plus Hospital
Seoul, Korea, Republic of
Hamchoon women clinic
Seoul, Korea, Republic of
Gangseo Mizmedi Hospital
Seoul, Korea, Republic of
Songnae Maria Hospital
Seoul, Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Cheil General Hospital & Women's Healthcare Center
Seoul, Korea, Republic of
Maria Hospital
Seoul, ´Shinseoul-dong, Dongdaemun-gu, Korea, Republic of
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01202123     History of Changes
Other Study ID Numbers: FE999906 CS10
Study First Received: September 3, 2010
Last Updated: February 20, 2014
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Menotropins
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on August 25, 2014