Status and phase
Conditions
Treatments
About
This is a phase II study intended to determine the effect of progesterone 5, 10 and 20 mg tablets compared to progesterone 100 mg capsules on the endometrial thickness of post-menopausal women under hormone therapy with estradiol.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Availability for the entire study period
Post-menopausal female defined as:
Females with an intact uterus
Moderate to severe climacteric vasomotor symptoms
Aged of at least 40 years but not older than 65 years
Body mass index (BMI) greater than or equal to 18.00 kg/m2 and below 30.00 kg/m2
Non- or ex-smoker;
Endometrium thickness ≤4 mm on ultrasonography at screening
Negative mammogram (dated < 2 years)
Negative Pap smear test (dated < 1 year)
Normal clinical breast examination
Normal pelvic examination
Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on physical examination, as determined by the medical investigator
Willingness to adhere to the protocol requirements as evidenced by the informed consent form (ICF) duly read, signed and dated by the subject
Exclusion criteria
Use of any estrogen, progestin, or estrogen/progestin drug products, androgens, selective estrogen receptor modulators (SERMs), phytoestrogen supplements or natural products (soy, black cohosh, dong quai) during the past 3 months before the screening visit
Use of any estrogen, progestin or androgen pellet or injectable therapy during the past 6 months before the screening visit
Contraindications to hormone therapy:
Presence of clinically significant screening ECG abnormalities as defined by medical judgment
Presence of polyps
Presence of uterine fibroids or other abnormalities affecting endometrial thickness measurement or precluding estrogen therapy
Known hypersensitivity to the active substances or to any of the excipients contained in the drug products in particular to soya or peanut, as well as hereditary problems of fructose intolerance or phenylketonuria
Participation in a concurrent clinical trial or another trial within the past 2 months
Use of any enzyme-modifying drugs, including strong inhibitors of cytochrome P450 (CYP) enzymes (such as cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem and HIV antivirals) and strong inducers of CYP enzymes (such as barbiturates, carbamazepine, glucocorticoids, phenytoin, rifampin and St John's Wort), in the previous 28 days before day 1 of this study
Maintenance therapy with any drug or significant history of drug dependency, drug abuse or alcohol abuse within the last 2 years
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
Any clinically significant illness in the previous 28 days before day 1 of this study
Any history of tuberculosis and/or prophylaxis for tuberculosis
Positive screening of alcohol and/or drugs of abuse
Positive results to HIV Ag/Ab combo, hepatitis B surface antigen or hepatitis C virus tests
Females who are pregnant according to a positive serum pregnancy test
Presumption of subject's poor reliability/cooperation
Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study
Primary purpose
Allocation
Interventional model
Masking
80 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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