NL-OMON44304
Completed
Not Applicable
A Phase 1, Randomized, Blinded, Placebo-Controlled, Dose-Ranging Study of MVT-602 in Healthy Premenopausal Women - MVT-602-1001 (CS0288)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- female infertility
- Sponsor
- Myovant Sciences GmbH
- Enrollment
- 40
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Not specified
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