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

NCT00775242 | Completed Phase 2

• 2 other identifiers: 02/PAF/060607/I/APL
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Menopause

Keywords

Menopause; Hormone Replacement Therapy; Microspheres; Progesterone; Estradiol; Hot flashes

Outcome Measures

Primary Outcomes (1)

• Change of frequency and intensity of vasomotor symptoms

  0, 1, 2, 3, 4, 5, 6 and 7 months

Secondary Outcomes (1)

• 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

  0, 1, 2, 3, 4, 5, 6 and 7 months

Study Arms (1)

Estradiol and progesterone injection

EXPERIMENTAL

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

Interventions

Estradiol and Progesterone DRUG

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.

Also known as: estrogens and progestines

Estradiol and progesterone injection

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centro A.F. de Estudios Tecnologicos, S.A.: lead

Study Sites (1)

Centro A.F. de Estudios Tecnologicos, S.A.

Mexico City, Mexico City, 03100, Mexico

Location

Related Publications (1)

• Cortes-Bonilla M, Alonso-Campero R, Bernardo-Escudero R, Francisco-Doce MT, Chavarin-Gonzalez J, Perez-Cuevas R, Chedraui P. Improvement of quality of life and menopausal symptoms in climacteric women treated with low-dose monthly parenteral formulations of non-polymeric microspheres of 17beta-estradiol/progesterone. Gynecol Endocrinol. 2016 Oct;32(10):831-834. doi: 10.1080/09513590.2016.1183628. Epub 2016 May 17.

  PMID: 27187320 DERIVED

MeSH Terms

Conditions

Hot Flashes

Interventions

Estradiol; Progesterone; Estrogens; Progestins

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pregnenediones; Pregnenes; Pregnanes; Corpus Luteum Hormones; Progesterone Congeners; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Manuel Cortes Bonilla, Ob/Gyn

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 16, 2008
• First Posted: October 20, 2008
• Study Start: April 1, 2007
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: August 25, 2009

Record last verified: 2009-08

Locations

ME (1)