A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 2 STUDY TO ASSESS THE INFLUENCE OF ESTETROL (E4) ON SKIN PARAMETERS IN POSTMENOPAUSAL WOMEN (PILOT STUDY)

Estetra Srl0 sites60 target enrollmentStarted: December 20, 2022Last updated: January 30, 2023

Conditions

Trial Snapshot

Phase: Phase 1
Status: Active, not recruiting
Sponsor: Estetra Srl
Enrollment: 60

Study Overview Eligibility Criteria Investigators Records & Identifiers Similar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type: Interventional clinical trial of medicinal product

Eligibility Criteria

Sex: Female

Inclusion Criteria

•1. Signed and dated written IC form and any required privacy authorization prior to the initiation of any study procedure, after the nature of the study has been explained according to local regulatory requirements
•2. Females, =40 to =65 years of age (inclusive) at randomization/treatment allocation visit with vasomotor menopausal symptoms.
•3. Postmenopausal status defined as any of the following:
•a. For NH subjects:
•? At least 12 months of spontaneous amenorrhea with serum FSH >40 mIU/mL and E2 <20 pg/mL (values obtained after washout of estrogen/progestin containing drugs, see exclusion criteria 18 and 20)
•? Or at least 6 months postsurgical bilateral oophorectomy
•b. For hysterectomized subjects:
•? Serum FSH >40 mIU/mL and E2 <20 pg/mL (values obtained after washout of estrogen/progestin containing drug, see exclusion criteria 18 and 20)
•? or at least 6 months postsurgical bilateral oophorectomy
•4. For subjects who have undergone hysterectomy and/or bilateral oophorectomy: documented surgery must have occurred at least 6 months prior to the start of screening. Hysterectomy can be total or subtotal (i.e., cervix was not removed)
•5. For NH subjects: uterus with bi-layer endometrial thickness = 4 mm on TVUS
•6. Body mass index (BMI) at screening between 18.5 kg/m² up to =35.0 kg/m², inclusive
•7. A mammogram that shows no sign of significant disease performed during screening or within 9 months prior to the start of screening
•8. Good physical and mental health, in the judgement of the Investigator as based on medical history, physical and gynecological examination, and clinical assessments performed prior to Visit 1
•9. Able to understand and comply with the protocol requirements, instructions, and protocol-stated restrictions
•10. Able and willing to complete study diaries and questionnaires
•Further inclusion criteria considering skin condition:
•11. Healthy skin in the measurement and biopsy areas with a hairless area sufficient for measurements
•12. Fitzpatrick skin type I–IV
•13. Willing to use the same skin care products during the study
•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 60
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

•1. History of malignancy
•2. Any clinically significant findings found by the Investigator at the breast examination and/or on mammography suspicious of breast malignancy
•3. Abnormal cervical cytology on PAP smear within the prior year
•4. For NH subjects: Presence of uterine cancer, endometrial hyperplasia, disordered proliferative or endometriumendometrial polyp(s); undiagnosed vaginal bleeding or abnormal uterine bleeding
•5. Systolic BP higher than 139 mmHg, diastolic BP higher than 89 mmHg
•6. History of venous or arterial thromboembolic disease or first-degree family history of VTE
•7. History of known acquired of congenital coagulopathy or abnormal coagulation factors (incl. known thrombophilia)
•8. Laboratory values of glycated hemoglobin above 7.5%
•9. Are current smokers (non-smokers of at least one year)
•10. Presence or history of gallbladder disease unless cholecystectomy has been performed
•11. Systemic lupus erythematosus
•12. Any malabsorption disorders including gastric bypass surgery
•13. History of acute liver disease in the preceding 12 months before the start of screening or presence or history of chronic or severe liver disease or liver tumors
•14. Chronic or current acute renal impairment
•15. Inadequately treated hyperthyroidism with abnormal thyroid stimulating hormone and free thyroxine at screening
•16. Porphyria
•17. Diagnosis or treatment of major psychiatric disorder in the judgement of the Investigator
•18. Use of estrogen/progestina up to: a.1 week before screening start for vaginal non-systemic hormonal products (rings, creams, gels); b. 4 weeks before screening start for vaginal or transdermal estrogen or estrogen/progestin products; c. 8 weeks before screening start for oral estrogen and/or progestin products and/or selective estrogen receptor modulator therapy; d.8 weeks before screening start for intrauterine progestin therapy; e. 3 months before screening start for progestin implants or estrogen alone injectable drug therapy; f. 6 months before screening start for estrogen pellet therapy or progestin injectable drug therapy
•19. Use of androgen/dehydroepiandrosterone containing drugs: a. 8 weeks before screening start for oral, topical, vaginal, or transdermal androgen; b.6 months before screening start for implantable or injectable androgen therapy
•20. Use of phytoestrogens or black cohosh for treatment of VMS up to 2 weeks before the start of screening
•21. Not willing to stop any hormonal products as described in exclusion criteria 18, 19 and 20, during their participation in the study
•22. History or presence of allergy/intolerance to the IMP or drugs of this class or any component of it, or history of drug or other allergy that, in the opinion of the Investigator contraindicates subject participation
•23. For NH subjects: history or presence of allergy to progestogens
•24. History of alcohol or substance abuse (including marijuana, even if legally allowed) or dependence in the previous 12 months before the start of screening as determined by the Investigator, based on reported observations
•25. Sponsor or CRO employees or employees under the direct supervision of the Investigator and/or involved directly in the study or close affiliation with the investigator (e.g., a close relative) or persons working at the CRO or at the site
•26. Subjects with known or suspected history of a clinically significant systemic disease, unstable medical disorders, life-threatening disease, or current malignancies that would pose a r

Investigators

Sponsor

Estetra Srl

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