A study of recombinant human follicle stimulating hormone (r-hFSH) of Intas Pharmaceuticals Ltd. with Gonal-F in healthy female subjects
- Registration Number
- CTRI/2018/11/016335
- Lead Sponsor
- Intas Pharmaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1) Healthy, adult, pre-menopausal (FSH level less than or equal to 25 mIU/mL) females between greater than or equal to 18 and less than or equal to 45 years of age (both inclusive) and having regular menstrual cycles of 25â??34 days before initiation of Leuprorelin acetate.
2) Body mass index (BMI) within the range of 18- 30 kg per meter square (Both inclusive)
3) Females who are sexually active and with male partners must be willing to use one of the following acceptable contraceptive methods throughout the study and for 30 days after the last study drug administration (Common locally used acceptable contraceptive methods)
a. Intra-uterine contraceptive device (without hormone release system).
OR
b. Double barrier contraceptive measure.
OR
c. Sterile male partner (vasectomized since at least 6 months)
OR
d. Females who have undergone tubal ligation.
4) Subjects should understand the requirements of the protocol, willing to follow the protocol-specified requirements as explained during informed consent and should be capable of providing written informed consent.
1) History of clinically significant illness and/or surgery within 4 weeks prior to dosing with leuprorelin acetate.
2) Any History of clinically significant history of neurological, endocrinal, cardiovascular (thrombo-embolic disorders), pulmonary (asthma), hematological (porphyria), immunologic, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
3) Thyroid function tests outside the normal reference limits of the laboratory.
4) History of clinically significant ovarian, uterine or mammary disease e.g. Polycystic ovary syndrome, ovarian hyperstimulation syndrome, endometriosis class 3 or 4, submucosal myoma uteri, Ovarian diseases.
5) History of undiagnosed abnormal vaginal bleeding and having irregular menstrual cycles.
6) Abnormal Papanicolaou smear within 12 months prior to administration of leuprorelin acetate.
7) Any clinically significant abnormality or abnormal laboratory test results found during medical screening or positive test for hepatitis B (HBsAg, HBcIgM), hepatitis C, or HIV antibody (I & II) found during medical screening.
8) Any clinically significant abnormal abdominal & pelvic ultrasound scan results found during medical screening.
9) Positive urine drug screen at baseline.
10) History of allergic reactions or hypersensitivity to leuprorelin acetate, r-hFSH (follitropin alfa), or similar related drugs.
11) Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.
12) Clinically significant electrocardiogram (ECG) abnormalities or vital sign abnormalities (systolic blood pressure less than 90 or more than 140 mmHg, diastolic blood pressure less than 60 or more than 90 mmHg, or pulse rate less than 50 or more than 100 bpm) at screening.
13) Donation of blood (1 unit or 350mL) or receipt of an investigational product, or participation in a drug research study within 6 months prior to receiving the first dose of study medicine.
14) Subjects with history of use of any Chinese hamster ovary (CHO) cell-derived product e.g. Inj FSH, Inj Bevacizumab, etc.
15) Use of medication other than topical products with significant systemic absorption
16) Pregnant or nursing (lactating) subject.
17) Smokers (tobacco users) or those who have stopped smoking within last 6 months prior to start of the study.
18) History of malignant diseases
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Bioequivalence of recombinant human follicle stimulating hormone (r-hFSH) solution for injection and Gonal-F® (Follitropin alfa) solution for injection <br/ ><br> <br/ ><br>Pharmacokinetics (PK) evaluationTimepoint: Time points for PK <br/ ><br> <br/ ><br>-1 hour, -0.5 hour and 0 hour pre dose and at 1, 3, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 28, 32, 36, 42, 48, 60, 72, 96, 120, 144 and 192 hours post dose <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method The safety and tolerability of recombinant human follicle stimulating hormone (r-hFSH) in comparison with Gonal-F® (Follitropin alfa) solution for injection <br/ ><br> <br/ ><br>Pharmacodynamics (PD) evaluationTimepoint: During entire duration of the study <br/ ><br> <br/ ><br>Time points for PD: <br/ ><br> <br/ ><br>-1 hour, -0.5 hour and 0 hour pre dose and at 1, 3, 6, 8, 12, 16, 20, 24, 28, 36, 48, 60, 72, 96 and 120 hours post dose