Pharmacokinetics of Injectable Estradiol and Progesterone Microspheres Suspension

• Status: Completed
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

Phase I pharmacokinetic study

Main objective:

To determine plasmatic profiles and pharmacokinetic parameters of estradiol and progesterone on each of the formulations studied, after multiple-dose administration

Study design:

Randomized, controlled, open-label, parallel, pharmacokinetic study

Sites: 1

Subjects: 30 postmenopausal women

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

Details

• Lead Sponsor: Productos Científicos S. A. de C. V.
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Polyestradiol phosphate; Progesterone

Criteria

Inclusion Criteria:

• Female

• 45 to 65 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

• History of serious neurologic disease

• Reduced mobility

• Anemia

• Previous or concomitant hormone therapy

• Previous or concomitant therapy with inhibitors or inductors of cytochrome