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Efficacy Study of Progesterone Tablet in Post-menopausal Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02841137
Recruitment Status : Completed
First Posted : July 22, 2016
Last Update Posted : June 11, 2018
Sponsor:
Information provided by (Responsible Party):
IBSA Institut Biochimique SA

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Menopause Drug: Progesterone Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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 - A Prospective, Open-Label, Randomized, Four-Arm, Parallel-Group, Phase II Clinical Trial
Study Start Date : June 2016
Actual Primary Completion Date : August 2, 2017
Actual Study Completion Date : April 25, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause

Arm Intervention/treatment
Experimental: progesterone 5 mg
progesterone 5 mg tablet
Drug: Progesterone
comparison of different dosages of drug towards the active comparator

Experimental: progesterone 10 mg
progesterone 10 mg tablet
Drug: Progesterone
comparison of different dosages of drug towards the active comparator

Experimental: progesterone 20 mg
progesterone 20 mg tablet
Drug: Progesterone
comparison of different dosages of drug towards the active comparator

Active Comparator: progesterone 100 mg
progesterone 100 mg capsule
Drug: Progesterone
comparison of different dosages of drug towards the active comparator




Primary Outcome Measures :
  1. endometrial thickness change towards baseline (mm) [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. histological assessment of the endometrium (presence of hyperplasia or proliferation) [ Time Frame: 3 months ]
  2. bleeding (presence or absence) [ Time Frame: everyday over 3 months ]
  3. quality of life (MENQOL Questionnaire) [ Time Frame: 3 months ]
  4. sleep scale from the Medical Outcomes Study (MOS) [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Availability for the entire study period
  2. Post-menopausal female defined as:

    • at least 12 consecutive months of spontaneous amenorrhea and
    • less than 10 years of spontaneous amenorrhea, and
    • Follicle-stimulating hormone (FSH) levels > 40 milli International Units/ml
  3. Females with an intact uterus
  4. Moderate to severe climacteric vasomotor symptoms
  5. Aged of at least 40 years but not older than 65 years
  6. Body mass index (BMI) greater than or equal to 18.00 kg/m2 and below 30.00 kg/m2
  7. Non- or ex-smoker;
  8. Endometrium thickness ≤4 mm on ultrasonography at screening
  9. Negative mammogram (dated < 2 years)
  10. Negative Pap smear test (dated < 1 year)
  11. Normal clinical breast examination
  12. Normal pelvic examination
  13. 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
  14. 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:

  1. 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
  2. Use of any estrogen, progestin or androgen pellet or injectable therapy during the past 6 months before the screening visit
  3. Contraindications to hormone therapy:

    • Active liver dysfunction or disease or history of severe liver disease
    • Known, suspected or past history of hepatic tumors (benign or malign)
    • Active or past history of arterial thromboembolic disease (e.g. angina, myocardial infarction, stroke, coronary heart disease, transient ischemic attack)
    • Active or past history of venous thromboembolism (e.g. deep venous thrombosis, pulmonary embolism) or active thrombophlebitis
    • Known, suspected or past history of breast cancer
    • Known, suspected or past history of estrogen-dependent or progestin-dependent malignant neoplasia (e.g. endometrial cancer)
    • Endometrial hyperplasia
    • Porphyria cutanea tarda
    • Genital bleeding
    • Untreated hypertension
    • Classical migraine
    • Partial or complete loss of vision or diplopia due to ophthalmic vascular disease
  4. Presence of clinically significant screening ECG abnormalities as defined by medical judgment
  5. Presence of polyps
  6. Presence of uterine fibroids or other abnormalities affecting endometrial thickness measurement or precluding estrogen therapy
  7. 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
  8. Participation in a concurrent clinical trial or another trial within the past 2 months
  9. 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
  10. Maintenance therapy with any drug or significant history of drug dependency, drug abuse or alcohol abuse within the last 2 years
  11. 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
  12. Serious psychiatric problems (whether or not receiving treatment) or in any case such as to compromise the patient's reliability
  13. Any clinically significant illness in the previous 28 days before day 1 of this study
  14. Any history of tuberculosis and/or prophylaxis for tuberculosis
  15. Positive screening of alcohol and/or drugs of abuse
  16. Positive results to HIV Ag/Ab combo, hepatitis B surface antigen or hepatitis C virus tests
  17. Females who are pregnant according to a positive serum pregnancy test
  18. Presumption of subject's poor reliability/cooperation
  19. Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02841137


Locations
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Canada, Quebec
Algorithme Pharma
Mont-Royal, Quebec, Canada, H3P3P1
Sponsors and Collaborators
IBSA Institut Biochimique SA
Investigators
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Principal Investigator: Deschamps Algorithme Pharma Inc
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Responsible Party: IBSA Institut Biochimique SA
ClinicalTrials.gov Identifier: NCT02841137    
Other Study ID Numbers: 16CDN-Prg02
First Posted: July 22, 2016    Key Record Dates
Last Update Posted: June 11, 2018
Last Verified: August 2017
Additional relevant MeSH terms:
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Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs