None listed
Conditions
Interventions
Intervention1: Briogyn (follitropin alfa), Cartridges in pen-injector devices for subcutaneous injection
: Tradename Briogyn
Generic name Follitropin alfa
Dosage form Cartridges in pen-injector devic
Sponsors
PSK Pharma LLC
Mudra Clincare
Eligibility
Inclusion criteria
Inclusion criteria: 1 Subjects who have used oral contraceptives for at least 3 months before study entry and are prepared to stop taking oral contraception from screening and to use effective non-hormonal methods of birth control until completion of 1 menstrual cycle after the last dose administration 2 Women of child bearing potential must agree to use effective non-hormonal contraception for birth control until completion of 1 menstrual cycle after the last dose administration 3 Subjects with a regular menstruation cycle (25 to 34 days) before initiation of oral contraception 4 Subjects with both ovaries 5 Subjects who are negative for drugs of abuse and alcohol tests at screening and each admission 6 Subjects who are healthy as determined by pre study medical history, physical examination and 12-Lead electrocardiogram (ECG) 7 Subjects whose clinical laboratory test results are not clinically relevant and are acceptable to the investigator 8 Subjects who are able and willing to give written informed consent
Exclusion criteria
Exclusion criteria: 1 Subjects who do not conform to the above inclusion criteria 2 Subjects with polycystic ovary syndrome 3 Subjects with developing follicles or solid ovarian cysts >2 cm or complex cysts regardless of size 4 Subjects with a history of hypersensitivity to FSH (Ovary Hyperstimulation Syndrome) 5 Subjects with impaired thyroid function (treated or untreated) 6 Subjects with a history of malignant disease 7 Subjects with aspartate aminotransferase and/or alanine aminotransferase >2 x upper limit of normal reference range 8 Subjects with other clinically relevant findings (ECG, blood pressure, physical, laboratory examination) 9 Subjects with a smoking history of more than 5 cigarettes per day 10 Subjects with evidence of abuse of drugs or alcoholic beverages 11 Subjects with a positive screen for hepatitis B surface antigen, antibodies to the hepatitis C virus or antibodies to the human immunodeficiency virus 1/2 12 Subjects who have participated in a clinical trial within the 3 months prior to this study 13 Subjects who are unlikely to co-operate with the requirements of the study 14 Subjects with symptoms of a clinically relevant illness during the 3 weeks prior to study day -1 15 Subjects who are pregnant, lactating or attempting to become pregnant 16 Subjects with any medical condition (including a known predisposition to porphyria) that, in the opinion of the investigator, could interfere with safety of the subject or interfere with the objectives of the study 17 Subjects who are vegans or have medical dietary restrictions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Baseline Corrected rFSH Area Under the Serum Concentration- time Curve from Zero to the Last Quantifiable Measurement [AUC(0-last)]Timepoint: From 0 (predose),0.5, 1, 3, 6, 9, 12, 16, 20, 21, 22, 23, 24, 25, 26, 27, 28, 48, 72, 96, 120, 144, 168 and 192 hours postdose.] | — |
Secondary
| Measure | Time frame |
|---|---|
| Baseline Corrected rFSH Maximum Serum Concentration (Cmax)Timepoint: [Time Frame: From 0 hours (predose) to 192 hours postdose.] | — |
Countries
India
Contacts
Public ContactDr S Sadgune
Mudra Clincare
Outcome results
None listed