Pharmacokinetics of Injectable Estradiol and Progesterone Microspheres Suspension

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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01293747

Enrollment

Registered

2011-02-11

Start date

2011-02-28

Completion date

2011-10-31

Last updated

2011-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Menopause

Keywords

Estrogen, Progesterone, Microspheres, Menopause, Pharmacokinetics

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.

Interventions

DRUGEstradiol + Progesterone

Estradiol 1 mg and progesterone 20 mg microspheres injectable aqueous suspension, intramuscular monthly injection for a total of 4 doses.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

45 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	0 - 60 days	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).

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026