Hirsutism related to Polycystic Ovarian Syndrome MedDRA version: 21.1 Level: PT Classification code 10036049 Term: Polycystic ovaries System Organ Class: 10038604 - Reproductive system and breast disorders
Conditions
Sponsors
Chemo Research S.L.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Two years postmenarcheal women of any ethnic origin between 14 and 40 years (inclusive at the time of enrolment), not seeking pregnancy. Female subjects at risk of pregnancy aged between 14 and 17 years (inclusive) provided that a. Applicable national, state and local laws allow subjects in this age group to consent/assent to receive contraceptive services, b. All applicable laws and regulations regarding the informed consent/assent of the subjects to participate in clinical trials are observed. 2. Diagnosed with PCOS according to the following criteria: a. Presence of hirsutism measured using an adapted mFG with a cut-off value of = 7 (at V1a only based on patient’s history or interview; to be determined only at Visit 1b) and b. Presence of one of the following criteria: 1. Oligomenorrhea (= 6 menses per year) while not using hormonal contraceptives 2. Polycystic ovaries defined as presence of 12 or more follicles measuring 2 - 9 mm throughout the entire ovary or an ovarian volume = 10 cm3 determined by ultrasound. This criterion applies only for subjects aged = 16 years due to the high incidence of multi-follicular ovaries in young subjects. (Ovarian cyst are any fluid filled structure > 30 mm in diameter that persisted for more than 2 cycles and enlarged follicles are any structure similar to an ovarian cyst that did not persist). 3. Informed consent form (ICF)/assent form signed voluntarily before any study-related procedure is performed; indicating that the subject understands the purpose of and procedures required for the study and is willing to participate in the study. 4. Body Mass Index (BMI): 18 kg/m2 = BMI =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnancy or wish for pregnancy. 2. Breastfeeding women. 3. Current smoker with age = 36 years and/or with BMI > 30 kg/m² (at the time of trial enrolment) 4. Abnormal finding on pelvic, breast or intravaginal ultrasound examination (or transabdominal ultrasound examination for adolescents) that in the investigator’s opinion contraindicates participation in the trial. 5. Women = 21 years of age with a Papanicolaou (pap) smear reading low-grade squamous intraepithelial lesion (LSIL) or higher at screening (or 6 months prior to screening date). Subjects with atypical squamous cells of undetermined significance (ASC-US) can be included if they are negative for high-risk Human papilloma virus (HPV) strains. Subjects 6.5%). Treatment with metformin is allowed only if it is expected to remain stable during the trial (defined as a stable dose for at least 3 months before V1a). 7. Anaemia (haemoglobin < 10 g/dL). 8. Subjects with disorders other than PCOS, that can result in menstrual irregularity and hyperandrogenism such as non-classic 21-hydroxylase deficiency, hyperprolactinemia, hypothyroidism, Cushing’s syndrome, nonclassical congenital adrenal hyperplasia and androgen-secreting tumours. 9. Known contraindication or hypersensitivity to ingredients or excipients of the IP, including: a. Presence or risk of a venous thromboembolism (VTE) b. Presence or risk of an arterial thromboembolism (ATE) c. Presence or history of pancreatitis, if it is associated with severe hypertriglyceridemia d. Presence or history of liver diseases in which liver function has not returned to normal (also Dubin-Johnson and Rotor syndrome) e. Current or previous liver tumours f. Known or suspected sex hormone-dependent malignant tumours (e.g., breast or endometrium) g. Undiagnosed vaginal bleeding h. Unexplained amenorrhoea i. Concomitant use of medicinal products containing ombitasvir/paritaprevir/ritonavir or dasabuvir 10. Uncontrolled chronic concomitant diseases (i.e., not on a stable treatment dose for at least 2 months at the time of consent/assent). 11. Severe Covid-19 disease or less than 3 months after hospitalisation due to a Covid-19 disease. 12. Evidence or history of alcohol, medication or drug abuse (within the last 12 months prior to consent/assent). 13. Known or suspected human immunodeficiency virus (HIV) and/or hepatitis infection at screening. 14. Previous intake of hormonal contraceptives within the last 3 months prior consent/assent or concomitant intake of hormonal contraceptives 15. Previous or concomitant intake of 5a-reductate inhibitors (e.g. flutamide) or similar inhibitors 16. Long-term treatment (longer than 7 consecutive days within a month prior to V1b) of any medication that might interfere with the efficacy of hormonal contraceptives. 17. Prohibited medication include the use of oestrogens, progestogens, strong microsomal enzyme-inducing drugs (intensive and moderate frequency). 18. Other prohibited medications include antiandrogens, insulin sensitizers or drugs that might interfere with blood pressure regulation, lipid profile or carbohydrate metabolism within the last 6 months prior to consent/assent. 19. Administration of human chorionic gonadotropin (hCG) or intake of co-medication containing hCG within a month prior to V1b. 20. Inositol treatment within the last 3 months prior to consent/assent. 21. Evidence or history
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the efficacy of LPRI-424 on hirsutism, measured by an adapted modified Ferriman-Gallwey (mFG) score based on the investigator decision against placebo ;Secondary Objective: To assess the safety of LPRI-424, bleeding pattern and health-related quality of life ;Primary end point(s): Changes from baseline in adapted mFG;Timepoint(s) of evaluation of this end point: After trial termination | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Changes in laboratory parameters from baseline Adverse events (AEs) Vital signs Clinical laboratory parameters Physical examination Electrocardiogram (ECG) Gynaecological examination Cervical cytology Changes in weight and waist Change in bleeding pattern from baseline Number of subjects with prolonged bleeding/spotting > 10 days IP acceptability based on IP satisfaction and wellbeing Changes in quality of life based on the Polycystic Ovarian Syndrome Questionnaire (PCOSQ) from baseline ;Timepoint(s) of evaluation of this end point: After trial termination | — |
Countries
Czech Republic, Hungary, Lithuania, Poland, Serbia, Slovakia, Spain, Ukraine
Contacts
Public ContactChief Scientific Officer
Chemo Research S.L.
Outcome results
None listed