Pharmacokinetics of Injectable Estradiol and Progesterone Microspheres Suspension

Study Overview
=================
Brief 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

Detailed 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.

Official Title
-----------------
Multiple-dose Pharmacokinetic Study of Two Aqueous Suspensions of Estradiol and Progesterone Microspheres (1 mg/20 mg & 0.5 mg/15 mg) for Intramuscular Administration, in Postmenopausal Volunteers.

Conditions
-----------------
Menopause

Intervention / Treatment
-----------------
* Drug: Estradiol + Progesterone
* Drug: Estradiol + Progesterone


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Estradiol 0.5 mg/Progesterone 15 mg microspheres<br>Estradiol 0.5 mg and progesterone 15 mg microspheres injectable aqueous suspension | Drug: Estradiol + Progesterone<br>* Estradiol 0.5 mg and progesterone 15 mg microspheres injectable aqueous suspension, intramuscular monthly injection for a total of 4 doses.<br>|
| Experimental: Estradiol 1 mg/Progesterone 20 mg microspheres<br>Estradiol 1 mg and progesterone 20 mg microspheres injectable aqueous suspension | Drug: Estradiol + Progesterone<br>* Estradiol 1 mg and progesterone 20 mg microspheres injectable aqueous suspension, intramuscular monthly injection for a total of 4 doses.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics | Estrogen and progesterone plasma concentrations and pharmacokinetic parameters. | 0 - 60 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Number of Participants with Adverse Events as a Measure of Safety and Tolerability. Adverse events will be evaluated through periodic clinical evaluations and laboratory tests (comparison between enrollment and discharge). | 0 - 60 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Estrogen, Progesterone, Microspheres, Menopause, Pharmacokinetics