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Pharmacokinetics of Injectable Estradiol and Progesterone Microspheres Suspension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Roberto Bernardo Escudero, Productos Científicos S. A. de C. V.
ClinicalTrials.gov Identifier:
NCT01293747
First received: February 10, 2011
Last updated: October 12, 2011
Last verified: October 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Menopause
 Drug: Estradiol + Progesterone
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:

MedlinePlus related topics: Menopause
U.S. FDA Resources

Further study details as provided by Productos Científicos S. A. de C. V.:

Primary Outcome Measures:
  • Pharmacokinetics [ Time Frame: 0 - 60 Days ] [ Designated as safety issue: No ]
    Estrogen and progesterone plasma concentrations and pharmacokinetic parameters.


Secondary Outcome Measures:
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 0 - 60 days ] [ Designated as safety issue: Yes ]
    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).


Estimated Enrollment: 30
Study Start Date: February 2011
Study Completion Date: October 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Estradiol 0.5 mg/Progesterone 15 mg microspheres
Estradiol 0.5 mg and progesterone 15 mg microspheres injectable aqueous suspension
 Drug: Estradiol + Progesterone
Estradiol 0.5 mg and progesterone 15 mg microspheres injectable aqueous suspension, intramuscular monthly injection for a total of 4 doses.
Experimental: Estradiol 1 mg/Progesterone 20 mg microspheres
Estradiol 1 mg and progesterone 20 mg microspheres injectable aqueous suspension
 Drug: Estradiol + Progesterone
Estradiol 1 mg and progesterone 20 mg microspheres injectable aqueous suspension, intramuscular monthly injection for a total of 4 doses.

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

Ages Eligible for Study:   45 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01293747

Locations
Mexico
Asociación Mexicana para la Investigación Clínica, A. C. (AMIC)
Pachuca, Hidalgo, Mexico, 42090
Sponsors and Collaborators
Productos Científicos S. A. de C. V.
Investigators
Principal Investigator: Roberto Bernardo, MSc Asociación Mexicana para la Investigación Clínica, A. C. (AMIC)
  More Information

No publications provided

Responsible Party: Roberto Bernardo Escudero, Principal Investigator, Productos Científicos S. A. de C. V.
ClinicalTrials.gov Identifier: NCT01293747     History of Changes
Other Study ID Numbers: 0903/I/PRO
Study First Received: February 10, 2011
Last Updated: October 12, 2011
Health Authority: Mexico: Secretaría de Salud

Keywords provided by Productos Científicos S. A. de C. V.:
Estrogen
Progesterone
Microspheres
Menopause
Pharmacokinetics

Additional relevant MeSH terms:
Estradiol
Polyestradiol phosphate
Progesterone
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estrogens
Hormones
 Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female
Progestins

ClinicalTrials.gov processed this record on May 19, 2013