Progesterone Microspheres Pharmacokinetic - Pharmacodynamic (PK-PD) Study

NCT01176175 | Completed Phase 1

• 1 other identifier: 0908/I/PRO
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Phase: I pharmacokinetic - pharmacodynamic (PK-PD) study. Main objective: To establish the minimum effective dose of progesterone microspheres suspension, which administered by weekly intramuscular injection, will be able to induce transformation from a proliferative endometrium to a secretory endometrium. Study design: Randomized, controlled, open-label, parallel, dose-response clinical trial. Sites: 1 Subjects: 48 postmenopausal women.

Conditions

Infertility

Keywords

Progesterone; Microspheres; postmenopausal; Luteal phase support

Outcome Measures

Primary Outcomes (1)

• Endometrial dating through histopathologic criteria.

  Endometrial dating according Noyes criteria as a measure of efficacy. At the moment of the biopsy, study subjects would have received 25 days of estradiol valerate pretreatment and 10 days of progesterone (investigational product); thus simulating the 25th day of a menstrual cycle. Efficacy will be measured as number of biopsies that have histological date according to cronological date.

  10 days

Secondary Outcomes (2)

• Pharmacokinetics

  0 -60 days.

• Adverse events

  0 - 65 days

Study Arms (4)

50 mg

EXPERIMENTAL

Progesterone microspheres injectable suspension 50 mg

Drug: Progesterone

100 mg

EXPERIMENTAL

Progesterone microspheres injectable suspension 100 mg

Drug: Progesterone

200 mg

EXPERIMENTAL

Progesterone microspheres injectable suspension 200 mg

Drug: Progesterone

300 mg

EXPERIMENTAL

Progesterone microspheres injectable suspension 300 mg

Drug: Progesterone

Interventions

Progesterone DRUG

Progesterone microspheres injectable suspension 50 mg, intramuscular weekly injection for a total of 7 doses.

50 mg

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female
• to 60 years old
• Able to read and write
• Postmenopausal
• Body Mass Index equal or below 34.99 kg/m2
• Healthy
• Normal uterus
• Time availability

You may not qualify if:

• 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
• Severe gastrointestinal disease

Sponsors & Collaborators

• Productos Científicos S. A. de C. V.: lead

Study Sites (1)

Asociación Mexicana para la Investigación Clínica, A. C. (AMIC)

Pachuca, Hidalgo, 42090, Mexico

Location

MeSH Terms

Conditions

Infertility

Interventions

Progesterone

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Study Officials

• Roberto Bernardo, MD MSc

  Asociación Mexicana para la Investigación Clínica, A. C. (AMIC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 4, 2010
• First Posted: August 5, 2010
• Study Start: August 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: February 1, 2011
• Last Updated: October 13, 2011

Record last verified: 2011-10

Locations

ME (1)