Female infertility MedDRA version: 20.0 Level: LLT Classification code 10021935 Term: Infertility, female, associated with anovulation System Organ Class: 100000004872
Conditions
Interventions
Product Name: N.A.
Product Code: MVT-602
Pharmaceutical Form: Solution for injection
INN or Proposed INN: N.A.
CAS Number: N.A.
Sponsors
Myovant Sciences GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subject is a premenopausal female between 18 and 35 years of age inclusive, at the time of the screening visit. A reference is made to the protocol for more inclusion criteria. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 85 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subject has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, gynecologic or endocrine disease (including type 1 or 2 diabetes mellitus) or other abnormality that may impact the ability of the subject to participate or potentially confound the study results. Subject has a history of menstrual cycle length that is typically shorter than 21 days or longer than 35 days when not using hormonal contraception. Subject has a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV), human immunodeficiency virus (HIV) antibody, determined from the screening visit. A reference is made to the protocol for more exclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Max LH: Maximum change from pre-trigger LH concentration. ;Timepoint(s) of evaluation of this end point: After database lock, before clinical study report.;Main Objective: •To characterize the exposure-response relationship of MVT-602 effects on luteinizing hormone (LH) concentrations after subcutaneous administration of single 0.1 to 3 µg doses of MVT-602 or placebo in healthy premenopausal women undergoing COS to inform dose selection of MVT-602 for subsequent studies.; Secondary Objective: •To characterize the LH, FSH, estradiol (E2), and progesterone (P) concentrations after administration of a single dose of MVT-602 (0.1 to 3 µg), placebo, or triptorelin in healthy premenopausal women undergoing COS. •To assess the time to ovulation after administration of a single dose of MVT-602 (0.1 to 3 µg), placebo, or triptorelin in healthy premenopausal women undergoing COS. •To assess the safety and tolerability after subcutaneous administration of single 0.1 to 3 µg doses of MVT-602, placebo, or triptorelin in healthy premenopausal women undergoing COS. •To assess the plasma pharmacokinetics (PK) of MVT-602 after subcutaneous administration of single 0.1 to 3 µg doses of MVT-602 in healthy premenopausal women undergoing COS. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Change from baseline and change from pre-trigger of LH, FSH, E2 and P serum concentrations •Duration (t) LH > 15 IU/L: Duration of time post-trigger LH concentrations are > 15 IU/L; •LH threshold: Number of subjects and percentage of subjects who achieve a maximum LH concentration > 50 IU/L within 48 hours after trigger administration; •P threshold: Number of subjects and percentage of subjects who achieve a post-trigger P concentrations = 5 ng/mL; •P Ratio: Maximum post-trigger P concentration: pre-trigger P concentration; •Time to ovulation: Time ovulation occurs as determined by TVUS (follicular rupture) relative to trigger administration; •Safety parameters including adverse events, vital sign measurements, clinical laboratory tests, electrocardiogram (ECG) parameters; •Plasma MVT-602 PK parameters: Area under the concentration-time curve extrapolated to infinity (AUC[0-8]), area under the concentration-time curve from time zero to last quantifiable time point (AUC[0-t]), maximum concentration (Cmax), time to maximum concentration (tmax), elimination half-life (t1/2), apparent clearance (CL/F), and apparent volume of distribution of the terminal phase (Vz/F); ;Timepoint(s) of evaluation of this end point: At screening, at different time points pre- and postdose, and at followup. | — |
Countries
Netherlands
Contacts
Public ContactElizabeth Migoya, PharmD
Myovant Sciences GmbH
Outcome results
None listed