A clinical study in women suffering from polycystic ovary syndrome (PCOS) to test the drug LPRI-424 (dienogest/ethinyl estradiol) during 9 months of treatment

Phase 1

• Conditions: Hirsutism related to Polycystic Ovarian Syndrome; MedDRA version: 21.1Level: PTClassification code 10036049Term: Polycystic ovariesSystem Organ Class: 10038604 - Reproductive system and breast disorders; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2021-002178-17-PL
• Lead Sponsor: Chemo Research S.L.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-02
• Last Update Posted: 19 February 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 367

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 < 35 kg/m2.
5. At screening, maximum systolic blood pressure (median value of 3 values) = 140 mm Hg and diastolic blood pressure (median value of 3 values) = 90 mm Hg.
6. Haematology and chemistry parameters, heart rate (HR) and electrocardiogram (ECG) within reference range, or showing no clinically relevant deviations, as judged by the investigator.
7. Willing to use trial medication for nine 28-day cycles.
8. Is consenting to use reliable nonhormonal contraceptive methods (condoms, female or male sterilisation or sexual abstinence) during the study from screening until the final examination visit.
9. Must be willing to avoid the use of all hair removal or growth procedures and products
apart from shaving during the trial and not to shave the hairs for a period of 14 days before
the modified adapted mFG score will be determined during study participation.
10. Has a good physical and mental health as determined on the basis of medical history and general physical examination performed at screening.
11. Willing to adhere to the prohibitions and restrictions specified in the protocol and being able to comply with the use of the trial medication or the use of the trial diary.
12. Agrees to not participate in any other clinical trials during the course of this trial.
Are the trial subjects under 18? yes
Number of subjects for this age range: 20
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 347
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 < 21 years of age do not require a Pap smear.
6. Poorly controlled diabetes (HgbA1c > 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified