Efficacy and Safety of Estradiol and Progesterone Microspheres for the Treatment of Climacteric Symptoms.

This study has been completed.
Sponsor:
Information provided by:
Centro A.F. de Estudios Tecnologicos, S.A.
ClinicalTrials.gov Identifier:
NCT00775242
First received: October 16, 2008
Last updated: August 21, 2009
Last verified: August 2009
  Purpose

During menopause a woman's body slowly produces less of the hormones estrogen and progesterone. Lower hormone levels in menopause may lead to hot flashes, vaginal dryness and osteoporosis. To help with these problems, women are often given estrogen or estrogen with progestin. The purpose of this study is to assess and compare the efficacy and safety of three doses of estradiol and progesterone for the treatment of the climacteric symptoms


Condition Intervention Phase
Menopause
Drug: Estradiol and Progesterone
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Comparative Efficacy and Safety Study of Three Different Doses of a Formulation Composed of Crystalline Estradiol and Progesterone Microspheres, Indicated for Monthly IM Injection for the Treatment ot Climacteric Symptoms.

Resource links provided by NLM:


Further study details as provided by Centro A.F. de Estudios Tecnologicos, S.A.:

Primary Outcome Measures:
  • Change of frequency and intensity of vasomotor symptoms [ Time Frame: 0, 1, 2, 3, 4, 5, 6 and 7 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency and intensity of vulvar and vaginal atrophy symptoms Vaginal pH Index of vaginal maturation (surface, intermediate and parabasal cells) Karyopiknotic index Lipids profile Utian quality of life scale Green climacteric symptoms scale [ Time Frame: 0, 1, 2, 3, 4, 5, 6 and 7 months ] [ Designated as safety issue: No ]

Enrollment: 103
Study Start Date: April 2007
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Estradiol and progesterone injection
Comparison of three different dosages of estradiol and progesterone a) 0.5 mg E/15 mg P; b) 1 mg E/20 mg P; c) 1 mg E/30 mg P
Drug: Estradiol and Progesterone
Injectable suspension of three different dosages of estradiol and progesterone a) 0.5 mg E/15 mg P; b) 1 mg E/20 mg P; c) 1 mg E/30 mg P. Administered on a monthly basis during a six-month period.
Other Name: estrogens and progestines
Drug: Estradiol and Progesterone
Injectable suspension of three different formulations of estradiol and progesterone a) 0.5 mg E/15 mg P; b) 1 mg E/20 mg P; c) 1 mg E/30 mg P. Each will be applied on a monthly basis during a six-month period
Other Names:
  • Estrogens
  • Progestins

Detailed Description:

Different formulations of estrogens and progestins have been used for the treatment of climacteric symptoms, however up to this date no formulation is completely satisfactory. Our company has developed a new technology for the preparation of controlled release bioerodible non-polymeric microspheres, these microspheres are capable of delivering doses of estradiol (E) and progesterone (P) at levels appropriate for the Hormonal Replacement Therapy (HRT) in order to relieve the climacteric symptoms. Non clinical and clinical studies have been conducted aimed at assessing the pharmacokinetics of these microspheres, at several doses of progesterone and estradiol. Results show that sustained plasma profiles for both steroids within the therapeutic range for several days are attained. On this basis, a new efficacy and safety study is going to be conducted with the purpose of assessing and defining the most appropriate doses of estradiol and progesterone for the HRT of the climacteric symptoms.

Three different doses of progesterone and estradiol (0.5 mg of E + 15 mg of P vs 1 mg of E + 20 mg of P vs 1 mg of E + 30 mg of P) will be compared in terms of their efficacy and safety to treat the climacteric symptoms in healthy postmenopausal women.

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 40 and 65 years.
  • Perimenopausal subjects: Women showing spontaneous amenorrhea during the last 11 months.
  • Postmenopausal subjects: Women with not less than 12 consecutive months of amenorrhea and FSH > 40 mIU/mL
  • Subjects showing vasomotor symptoms, not less than 3 hot flashes in a day or not less than 21 hot flashes in a week
  • Healthy subjects determined on the basis of a satisfactory complete clinical history, clinical laboratory tests, cervical cytology, endometrium biopsy and vaginal pelvic ultrasonography.
  • Subjects not receiving any hormonal treatment.

Exclusion Criteria:

  • Subjects with background of endometrial hyperplasia or endometrial cancer.
  • Subjects with endometrial hyperplasia or endometrial cancer assessed by endometrial biopsy.
  • Perimenopausal subjects with background of abnormal uterine bleeding unless the Principal Clinical Investigator considers that this abnormality is secondary to the menopausal condition.
  • Subjects with hypersensitivity to any medicament.
  • Subjects with direct family background of breast cancer.
  • Subjects with background of cardiovascular disease, renal, hepatic, metabolic, gastrointestinal, neurologic, endocrine, gynecologic disease including dysfunctional uterine bleeding, cervico uterine dysplasia, cancer, anemia, emotional disorders, or any other chronic degenerative disorders which could affect her participation in the study.
  • Subjects who require any medicament in the course of the study unless the Principal Clinical Investigator considers that there is no pharmacological interaction.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00775242

Locations
Mexico
Centro A.F. de Estudios Tecnologicos, S.A.
Mexico, DF, Mexico, 03100
Sponsors and Collaborators
Centro A.F. de Estudios Tecnologicos, S.A.
Investigators
Principal Investigator: Manuel Cortes Bonilla, Ob/Gyn
  More Information

No publications provided

Responsible Party: Juan Angeles Uribe, Centro A.F. de Estudios Tecnológicos, S.A.
ClinicalTrials.gov Identifier: NCT00775242     History of Changes
Other Study ID Numbers: 02/PAF/06, 0607/I/APL
Study First Received: October 16, 2008
Last Updated: August 21, 2009
Health Authority: Mexico: Federal Commission for Protection Against Health Risks

Keywords provided by Centro A.F. de Estudios Tecnologicos, S.A.:
Menopause
Hormone Replacement Therapy
Microspheres
Progesterone
Estradiol
Hot flashes

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

ClinicalTrials.gov processed this record on August 25, 2014