Status:
COMPLETED
A Study Comparing MENOPUR in a Pen Formulation With a Powder and Solvent Formulation in Healthy Women
Lead Sponsor:
Ferring Pharmaceuticals
Conditions:
Infertility, Female
Eligibility:
FEMALE
21-40 years
Phase:
PHASE1
Brief Summary
MENOPUR is a human menotrophin product, with a combination of human follicle-stimulating hormone (FSH) and luteinizing hormone (LH) activity. Human chorionic gonadotrophin (hCG) is the major contribut...
Eligibility Criteria
Inclusion
- Key
- Chinese women between the ages of 21 to 40 years at the time of signing the informed consent form
- Non-users or users of the combined oral contraceptive (COC) pill who describe experiencing menstrual cycles of 24 to 35 days in duration (both inclusive)
- Healthy according to medical history, physical and gynecological examinations, vital signs, 12-lead electrocardiogram, and laboratory tests in blood and urine
- Serum FSH levels ≤5 IU/L and estradiol levels ≤50 pg/mL on Day -3 and Day -1 in TP1
- Key
Exclusion
- Any finding at the gynecological examination, transvaginal ultrasound or by cervical smear that is considered medically important
- A history of medical problems that could affect the functioning of the reproductive organs (ovaries and womb)
- A history of any medical problems that may prevent use of the combined hormonal contraceptive pill
Key Trial Info
Start Date :
November 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 15 2022
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT04902131
Start Date
November 2 2021
End Date
August 15 2022
Last Update
August 24 2022
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Ferring investigational site
Nanjing, Gaoxin District, China, 210032
2
Ferring investigational site
Nanjing, China, 210029