E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10021935 |
E.1.2 | Term | Infertility, female, associated with anovulation |
E.1.2 | System Organ Class | 100000004872 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
•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. |
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E.2.2 | Secondary objectives of the trial |
•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.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Max LH: Maximum change from pre-trigger LH concentration. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After database lock, before clinical study report. |
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E.5.2 | 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-∞]), 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);
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
At screening, at different time points pre- and postdose, and at followup. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | |