Clinical trial NCT01293747: Pharmacokinetics of Injectable Estradiol and Progesterone Microspheres Suspension
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Menopause
Keywords: Estrogen
Progesterone
Microspheres
Menopause
Pharmacokinetics
Lead sponsor: Productos Científicos S. A. de C. V.
Sponsor class: INDUSTRY
First posted: 2011-02-11
Enrollment: 30
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pharmacokinetics
timeFrame: 0 - 60 Days
Secondary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 0 - 60 days
Other outcomes:
Locations:
city: Pachuca
country: Mexico
facility: Asociación Mexicana para la Investigación Clínica, A. C. (AMIC)
state: Hidalgo
Study officials:
affiliation: Asociación Mexicana para la Investigación Clínica, A. C. (AMIC)
name: Roberto Bernardo, MSc
role: PRINCIPAL_INVESTIGATOR
References: