Efficacy Study of Progesterone Tablet in Post-menopausal Women

NCT02841137 | Completed Phase 2

• 1 other identifier: 16CDN-Prg02
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Menopause

Outcome Measures

Primary Outcomes (1)

• endometrial thickness change towards baseline (mm)

  3 months

Secondary Outcomes (4)

• histological assessment of the endometrium (presence of hyperplasia or proliferation)

  3 months

• bleeding (presence or absence)

  everyday over 3 months

• quality of life (MENQOL Questionnaire)

  3 months

• sleep scale from the Medical Outcomes Study (MOS)

  3 months

Study Arms (4)

progesterone 5 mg

EXPERIMENTAL

progesterone 5 mg tablet

Drug: Progesterone

progesterone 10 mg

EXPERIMENTAL

progesterone 10 mg tablet

Drug: Progesterone

progesterone 20 mg

EXPERIMENTAL

progesterone 20 mg tablet

Drug: Progesterone

progesterone 100 mg

ACTIVE COMPARATOR

progesterone 100 mg capsule

Drug: Progesterone

Interventions

Progesterone DRUG

comparison of different dosages of drug towards the active comparator

progesterone 10 mg; progesterone 100 mg; progesterone 20 mg; progesterone 5 mg

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Availability for the entire study period
• 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
• 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

You may not qualify if:

• 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:
• 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

Sponsors & Collaborators

• IBSA Institut Biochimique SA: lead

Study Sites (1)

Algorithme Pharma

Mount Royal, Quebec, H3P3P1, Canada

Location

MeSH Terms

Interventions

Progesterone

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Study Officials

• Deschamps

  Algorithme Pharma Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2016
• First Posted: July 22, 2016
• Study Start: June 1, 2016
• Primary Completion: August 2, 2017
• Study Completion: April 25, 2018
• Last Updated: June 11, 2018

Record last verified: 2017-08

Locations

CA (1)