Effects of Hormone Replacement Therapy on Arthralgia in Postmenopausal Women

NCT02838576 | Unknown Phase 2

• 1 other identifier: 16-0235
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Arthralgia has been a common complaint in postmenopausal period which seems to be involved with estrogen depletion, although, its pathophysiology isn´t completely clarified. It seems to relate with the level of physical activity, climacteric symptoms and pain catastrophizing. In view of the multiple dimensions involved in arthralgia in postmenopausal women which characterize it as a complex phenomenon, this study aims to describe the effects of hormone replacement therapy in women aged between 45 and 55 years, considering estrogen as a possible anti-nociceptive factor.

Conditions

Arthralgia

Outcome Measures

Primary Outcomes (1)

• Arthralgia

  Arthralgia´ll be measured by numeric scale (0-10).

  6 months

Secondary Outcomes (7)

• Climacteric symptoms

  6 months

• Level of physical activity

  6 months

• Pain Catastrophizing

  6 months

• Health-related quality of life

  6 months

• Depression

  6 months

Study Arms (2)

Conjugated Equine Estrogen

EXPERIMENTAL

Thirty-six healthy postmenopausal women aged between 45 and 55 years will receive 0,625 mg/day conjugated equine estrogen (CEE) for 12 weeks. These 1 active pill containing conjugated equine estrogen, 0,625 mg will be provided by a laboratory with no trademark identification. The bottles will be numbered in code by a pharmaceutist not involved directly in study and they will donated to volunteers. During the intervening period, use of conjugated equine estrogen, there will be blinding. After this phase, blinding will be interrupted in order to identify volunteers who used the active drug.

Drug: Conjugated Equine Estrogen

Placebo

PLACEBO COMPARATOR

Thirty-six healthy postmenopausal women aged between 45 and 55 years will receive placebo pills, identical in size, shape and color to the active drug, via oral administration, for 12 weeks. The bottles, without trademark identification, will be numbered in code by a pharmaceutist not involved directly in study and they will donated to volunteers. During the intervening period, use of placebo, there will be blinding. After this phase, blinding will be interrupted in order to identify volunteers who used the active drug and placebo.

Drug: Placebo

Interventions

Conjugated Equine Estrogen DRUG

Use of conjugated equine estrogen for 12 weeks. Adherence will be monitored during periodical hospital visits in order to receive pills.

Also known as: Drug active

Conjugated Equine Estrogen

Placebo DRUG

Use of placebo for 12 weeks. Adherence will be monitored during periodical hospital visits in order to receive pills.

Placebo

Eligibility Criteria

• Age: 45 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• age between 45 and 55 years
• chronic arthralgia related to climacteric
• regular mammography and pap smear test in the last twelve months
• availability to attend hormone replacement therapy
• maximum of ten years of amenorrhea according to the criteria of Stages of Reproductive Aging Workshop (STRAW)
• without use of hormone replacement therapy, at least, previous six months
• no contraindication to hormone replacement therapy (current or past of breast and / or cervical cancer, severe current or recent heart disease, thromboembolism, hypertension with no control, metabolic diseases (but stable thyroid disease) and endometrial hyperplasia to be enlightened
• Informed consent

You may not qualify if:

• autoimmune diseases
• visceral pain (chronic pelvic pain, dyspareunia, irritable bowel syndrome)
• systemic diseases (rheumatic, neurological, oncology, sexually transmitted infection)
• body mass index of 30 or greater
• soy diet
• abuse of alcohol and drugs
• large surgeries

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Comitê de Ética em Pesquisa do Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

RECRUITING

MeSH Terms

Conditions

Arthralgia

Interventions

Estrogens, Conjugated (USP); Bulk Drugs

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pharmaceutical Preparations

Study Officials

• Maria Celeste Osório Wender, Ph.D

  Hospital de Clínicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Celeste Osório Wender, Ph.D

CONTACT

55 51 3359-8117; mceleste@ufrgs.br

Fernanda Vargas Ferreira, Ph.D

CONTACT

55 51 3359-8117; fernandaferreira@unipampa.edu.br

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2016
• First Posted: July 20, 2016
• Study Start: March 1, 2017
• Primary Completion: December 2, 2019
• Study Completion: December 31, 2020
• Last Updated: October 14, 2019

Record last verified: 2019-01

Locations

BR (1)