Effect on the endometrial thickness of progesterone 25 mg solution administered by oral route in post-menopausal women under treatment with estrogens, compared to progesterone 200 mg capsules.

• Conditions: hormone replacement therapy of menopause (as progestin therapy in association to estrogen replacement therapy); MedDRA version: 17.0Level: PTClassification code 10020388Term: Hormone replacement therapySystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2014-001185-10-IT
• Lead Sponsor: IBSA Institut Biochimique SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07-03
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

-Signed written informed consent prior to inclusion in the study.
-Post-menopausal women defined as:
* 12 months of spontaneous amenorrhea
* or 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/ml
* and since maximum 2 years, with intact uterus.
-Climateric symptoms.
-Age 40-65.
-BMI: 18-Negative mammogram and normal clinical breast examination.
-Negative Pap test.
-Normal pelvic examination.
-Evaluable screening endometrial biopsy (i.e., endometrial tissue sufficient for diagnosis) displaying no findings of endometrial hyperplasia or cancer.
-Endometrium thickness < 5 mm at screening.
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 36
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 36

Exclusion Criteria

-Estrogen, progestin or estrogen/progestin drug products during the past 3 months.
-Contraindications to HRT:
*known hypersensitivity to the active substances or to any of the excipients;
*acute or history of severe liver disease;
*porphyria;
*undiagnosed genital bleeding;
*known, past or suspected breast cancer;
*known, past or suspected estrogen-dependent malignant tumors or pre-cancerous conditions (e.g. endometrial cancer);
*known, past or suspected hepatic tumors (benign or malign);
*severe hypertriglyceridemia;
*endometrial hyperplasia;
*previous or current venous thromboembolism (e.g. deep venous thrombosis, pulmonary embolism, thrombophlebitis);
*high risk of arterial or venous thrombosis;
*known thrombophilic disorders;
*active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction, stroke).
*active or history of leiomyomas (uterine fibroids) or endometriosis;
*risk factors for estrogen-dependent tumors;
-Presence of uterine fibroids or polyps or other factors affecting endometrial thickness measurement.
-Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption, fructose intolerance or sucrose isomaltase deficiency (because of the excipients contained in Progynova, i.e. lactose and saccharose).
-Allergy to peanuts (because of the excipient contained in Prometrium, i.e. arachis oil).
-Participation in a concurrent clinical trial or another trial within the past 2 months.
-Use of concomitant medications, including OTC, that might interfere with the study evaluation (see section 7.4).
-Intake of phytoestrogens through food or natural products.
-Presence of any medical condition or other circumstances which would significantly decrease the chance of obtaining reliable data, achieving study objectives or completing the study.
-Serious psychiatric problems (whether or not receiving treatment) or in any case such as to compromise the patient’s reliability.
-Presumption of poor reliability/cooperation.
-Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Secondary Objective: Histological assessment of the endometrium; Incidence of withdrawal bleeding and/or irregular bleeding; Safety evaluation (adverse events).<br>;Primary end point(s): evolution of the endometrial thickness after treatment with estrogen and progesterone;Timepoint(s) of evaluation of this end point: 3 months (90 days);Main Objective: to evaluate the protective effect of progesterone on the endometrium of post-menopausal women under HRT, assessed by measurement of endometrial thickness, upon administration of two dosing schemes (continuous sequential and combined continuous) of progesterone 25 mg solution administered by oral route, compared to an oral progesterone 200 mg capsule (Prometrium).

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): evolution of the endometrial thickness after treatment with estrogen and progesterone; hystological evalutaion of the endometrium; incidence of regular or irregular vaginal bleeding; safety evaluation (adverse events);Timepoint(s) of evaluation of this end point: depending on the end-point: day 17, 1 month (day 34), 3 months (day 90) or throughout the whole study duration