Pharmacokinetics of Injectable Estradiol and Progesterone Microspheres Suspension

Productos Científicos S. A. de C. V.

Status and phase: Completed; Phase 1

Conditions: Menopause

Treatments: Drug: Estradiol + Progesterone

Study type: Interventional

Funder types: Industry

Identifiers

NCT01293747

0903/I/PRO

Details and patient eligibility

About

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

Full description

Sites: 1

Phase: 1

Main objective:

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

Secondary objectives:

To determine bioavailability of each of the formulations studied, after multiple-dose-administration. Describe tolerability of each of the formulations studied, after multiple-dose administration.

Study design: Randomized, controlled, open-label, parallel, pharmacokinetic study

Investigational Products:

• Estradiol and progesterone microspheres aqueous suspension (1 mg/20 mg)
• Estradiol and progesterone microspheres aqueous suspension (0.5 mg/15 mg)

Study subjects: 30 postmenopausal women 45 - 65 years old

Brief description: After written informed consent, 30 eligible women will be randomized to study treatments (one IM injection each 28 days, for a total of 4 doses). Blood samples will be obtained for pharmacokinetic study.

Enrollment: 30 estimated patients

Sex: Female

Ages: 45 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Estradiol 0.5 mg/Progesterone 15 mg microspheres

Experimental group

Description:

Estradiol 0.5 mg and progesterone 15 mg microspheres injectable aqueous suspension

Treatment:

Drug: Estradiol + Progesterone

Drug: Estradiol + Progesterone

Estradiol 1 mg/Progesterone 20 mg microspheres

Experimental group

Description:

Estradiol 1 mg and progesterone 20 mg microspheres injectable aqueous suspension

Treatment:

Drug: Estradiol + Progesterone

Drug: Estradiol + Progesterone