Status:
COMPLETED
Clinical Pharmacological Study of GnRH Antagonist, Cetrorelix for Healthy Female Volunteer
Lead Sponsor:
Nippon Kayaku Co., Ltd.
Collaborating Sponsors:
Shionogi
AEterna Zentaris
Conditions:
Premenopause
Eligibility:
FEMALE
18-25 years
Phase:
NA
Brief Summary
GnRH analogs are globally used for assisted reproduction in infertile patients. To date, in healthy female volunteers the pharmacokinetic and pharmacodynamic profiles of cetrorelix when administered i...
Detailed Description
To evaluate that effect on LH surge, we investigated the efficacy of cetrorelix in delaying the start of the LH surge in comparison with the control menstrual cycle when saline was administered, and a...
Eligibility Criteria
Inclusion
- a BMI of 18 years old and \<18 and 25 years old and \>25
- menstrual cycles was within the range of 25\~31 days
Exclusion
- use of a drug (e.g., oral contraceptives, drugs for treatment of hyperprolactinemia, GnRH agonists, sex steroid hormones, psychoactive drugs, etc.)
- serious disease of the endocrine system, liver, kidney, heart, lung, digestive system, etc.
- a generalized drug allergy
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00628121
Start Date
April 1 2006
End Date
February 1 2007
Last Update
March 4 2008
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Kitasato University East Hospital
Sagamihara, Kanagawa, Japan, 228-8520