Progesterone Microspheres Pharmacokinetic - Pharmacodynamic (PK-PD) Study

• Status: Completed
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

Phase: I pharmacokinetic - pharmacodynamic (PK-PD) study. Main objective: To establish the minimum effective dose of progesterone microspheres suspension, which administered by weekly intramuscular injection, will be able to induce transformation from a proliferative endometrium to a secretory endometrium.

Study design: Randomized, controlled, open-label, parallel, dose-response clinical trial.

Sites: 1 Subjects: 48 postmenopausal women.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Productos Científicos S. A. de C. V.
• Treatments: Progesterone

Criteria

Inclusion Criteria:

• Female

• 45 to 60 years old

• Able to read and write

• Postmenopausal

• Body Mass Index equal or below 34.99 kg/m2

• Healthy

• Normal uterus

• Time availability

Exclusion Criteria:

• Hypersensitivity to progesterone or related compounds

• Hypersensitivity to estrogens

• Hysterectomy

• History or present hormone-dependent tumor

• History or present uterine cervix dysplasia

• Abnormal and clinically-significant laboratory test results

• Family history of breast cancer

• History of thromboembolic disease

• Non-controlled hypertension

• History of stroke

• History of cardiac valve surgery

• Renal failure

• Hepatic failure

• Non-controlled diabetes

• Severe gastrointestinal disease

• History of serious neurologic disease

• Reduced mobility

• Anemia

• Previous or concomitant hormonal therapy

• Previous or concomitant therapy with inhibitors or inductors of cytochrome