female infertility induction of ovulation
Conditions
Interventions
A single dose of study treatment will be administered as a subcutaneous
injection
Sponsors
Myovant Sciences GmbH
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Premenopausal female between 18 and and 35 years of age inclusive, at the time of signing the informed consent. 2. Healthy as determined by the investigator, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. 3. A history of regular menstrual periods (3 or more consecutive days of bleeding requiring protection) with cycle lengths of 21 to 35 days for the 3 months prior to study enrollment. 4. Subject agrees to use one of the nonhormonal contraception methods listed in Section 5.6.1 for the screening period, treatment period, and until the final study visit 30 to 45 days after the dose of study treatment 5. Body Mass Index within the range 18.0-30.0 kg/m2 (inclusive). 6. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Exclusion criteria
Exclusion criteria: 1. The subject has a medical history of infertility or ovarian hyperstimulation syndrome, or received treatment for infertility within 3 months immediately prior to screening 2. A positive Hepatitis B surface antigen or positive Hepatitis C antibody result at Screening. 3. A positive test for human immunodeficiency virus (HIV) antibody at Screening. 4. The subject has a positive pre-study drug/alcohol screen. There will be screened for Amphetamines, barbiturates, cocaine and opiate 5. Screening aspartate aminotransferase (AST), alanine aminotransferase (ALT), or direct bilirubin value greater than 1.25X the upper limit of normal (ULN) or serum creatinine greater than 1.5X ULN. A single repeat is allowed for eligibility determination. 6. Serum TSH/Prolactin outside normal range or history of thyroid disease or hyperprolactinemia. 7. Current use (within 1 month of study Day 1) of tobacco/nicotine/vaping/e-cig products. 8. History of regular alcohol consumption within 6 months of the study defined as: an average weekly intake of >7 drinks. One drink is equivalent to 12 g of alcohol: 12 ounces (360 mL) of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits. 9. The subject has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer). 10. Pregnant females as determined by positive serum or urine human chorionic gonadotropin test at Screening or prior to dosing. 11. Lactating females. 12. Donation of blood or blood products within the 60-day period before Day 1 and intention to donate blood or blood products within the 60-day period after Day 4 of study. 13. History of sensitivity to any of the study treatment, or components thereof, or a history of drug or other allergy that, in the opinion of the investigator or sponsor Medical Monitor, contraindicates their participation. 14. Subjects with a history of sensitivity to heparin or heparin-induced thrombocytopenia should not be enrolled. 15. The subject has uncontrolled or clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, neoplastic or endocrine disease or other abnormality that may impact the ability of the subject to participate or potentially confound the study results. 16. Subjects with a pre-existing condition interfering with normal hepatic and/or renal function, that could interfere with the metabolism and/or excretion of the study treatment. 17. Use of: * Prescription or non-prescription drugs, including herbal and dietary supplements within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior dosing of study treatment; * Hormonal preparations or analogues, including oral contraceptive pills and hormonal IUDs, within 1 month prior dosing of study treatment; * GnRH/lutenizing hormone releasing hormone (LHRH) agonists within two-times the dose interval prior to dosing of study treatment (e.g., a 3-month depot injection of leuprolide acetate would require a 6-month washout); unless in the opinion of the investigator and sponsor the medication will not interfere with the study procedures or compromise study objectives or subject safety. 18. The subject*s systolic blood pressure is ou
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety parameters including: adverse events , change in vital signs, laboratory tests, and electrocardiograms (ECG). | — |
Secondary
| Measure | Time frame |
|---|---|
| Plasma pharmacokinetic parameters: AUC(0 *), AUC(0-t), AUC(0-24), Cmax, tmax, t*, CL/F, and Vz/F. Change in luteinizing hormone (LH), follicle stimulating hormone (FSH), estradiol (E2), progesterone (P). | — |
Countries
Netherlands
Outcome results
None listed