Status:
COMPLETED
Pergoveris FD and Liquid China BE Study
Lead Sponsor:
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Conditions:
Healthy
Eligibility:
FEMALE
18-40 years
Phase:
PHASE1
Brief Summary
The main purpose of this study is to assess the bioequivalence (BE) of the fixed combination of follitropin alfa and lutropin alfa in Pergoveris freeze-dried (FD) (Test 1) or in Pergoveris Liquid (Tes...
Eligibility Criteria
Inclusion
- Participants who are overtly healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, and ECG, blood pressure (systolic and diastolic) and pulse rate
- Participants who have a negative serum pregnancy test before starting Marvelon and on the days before the Pergoveris or Gonal-f/Luveris dose
- Participants who are taking an oral contraceptive pill (OCP) for at least 1 month prior to Screening and are willing to take the combined oral contraceptive pill (COCP) during the study and to recommence taking their own OCP from Day 55 after the first Pergoveris or Gonal-f/Luveris dosing
- Participants with normal baseline follicle stimulating hormone (FSH) (\< 12 IU/L) and estradiol (E2) levels \[\<= 100 picograms per millilitre (pg/mL)\] and showing follicle size \<= 11 millimeter (mm)
- Participants who had a normal Thinprep cytologic test (TCT) within the last 1 year before Screening (timeframe to be adjusted based on local routine clinical care). If not performed in routine clinical care, participant must be willing to undergo a cervical smear at Screening
- Participants who have a body weight within \>= 45 kilogram (kg) and body mass index within the range 18.5 to 29.9 kilogram per meter square (kg/m\^2) (inclusive)
- Other protocol defined inclusion criteria could apply
Exclusion
- Participants with any condition that, in the Investigator's opinion, constitutes an inappropriate risk or a contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation
- Participants with clinically significant abnormalities of the genital organs as determined by gynecological examination and Trans Vaginal Ultrasound Scan (TVUS) and based on the Investigator's judgment (example., ovarian tumors, non-functional ovarian cysts, endometrial hyperplasia)
- Participants with polycystic ovaries as defined by at least 1 of the following 2 criteria fulfilled: More than 12 follicles \< 10 mm mean diameter in either ovary or at least one ovary of \> 10 mL volume
- Participants with ovarian follicle-like structures larger than 11 mm (at Screening)
- Participants with positive result for syphilis, human immunodeficiency virus, hepatitis B surface antigen or hepatitis C Virus
- Participants using drugs that may reduce the effectiveness of COCP (e.g., phenytoin, barbiturates, primidone, carbamazapine, oxcarbazepine, topiramate, felbamate,rifampicin, nelfinavir, ritonavir, griseofulvin, oral ketoconazole, and herbal remedies containing Hypericum perforatum \[St. John's Wort\])
- Participation in any clinical study within 3 months or 5 half-lives, whichever is longer, prior to Screening or during participation Unsuccessful downregulation, demonstrated by serum luteinising hormone (LH) or FSH levels \> 2.0 IU/L or E2 levels \> 100 pg/mL the day before Pergoveris or Gonal-f/Luveris administration, or showing follicle size \> 11 mm
- Participants vaccinated with any Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-Cov-2) vaccine within 4 weeks before administration of study intervention (Marvelon)
- Other protocol defined exclusion criteria could apply
Key Trial Info
Start Date :
May 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 28 2022
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT04899193
Start Date
May 8 2021
End Date
May 28 2022
Last Update
June 15 2022
Active Locations (1)
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1
Xuanwu Hospital, Capital Medical University
Beijing, China, 100053