Effects of Hormone Replacement Therapy on Arthralgia in Postmenopausal Women

NCT ID: NCT02838576

Last Updated: 2019-10-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2020-12-31

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.

Detailed Description

This study is a randomized double-blind controlled clinical trial with postmenopausal women aged between 45 and 55 years with chronic arthralgia related to climacteric. They will be evaluated climacteric symptoms, pain intensity, level of physical activity, pain catastrophising, depression, anxiety, quality of sleep and quality of life. The volunteers will be randomized, in the proportion 1:1, to treatment with either 0,625 mg conjugated equine estrogen, via oral administration, for 12 weeks or placebo, via oral administration, for 12 weeks. The randomization will be performed by a computer-generated random numbers list. The investigators will be blinded until completion of 12 weeks. Evaluation of climacteric symptoms, pain intensity, level of physical activity, pain catastrophising, depression, anxiety, quality of sleep and quality of life will be performed in the hospital at baseline, 1, 2, 3, 6 months and 15 days. In each visit, participants will be evaluated about adverse effects such as diarrhea, nausea and vomit.

Conditions

Arthralgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Conjugated Equine Estrogen

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.

Group Type: EXPERIMENTAL

Conjugated Equine Estrogen

Intervention Type: DRUG

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

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Conjugated Equine Estrogen

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

Drug active

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria Celeste Osório Wender, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clínicas de Porto Alegre

Locations

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

Porto Alegre, Rio Grande do Sul, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Maria Celeste Osório Wender, Ph.D

Role: CONTACT

mceleste@ufrgs.br

55 51 3359-8117

Fernanda Vargas Ferreira, Ph.D

Role: CONTACT

fernandaferreira@unipampa.edu.br

55 51 3359-8117

Facility Contacts

Maria Celeste Osório Wender, Ph.D

Role: primary

mceleste@ufrgs.br

+55513359-8117

Fernanda Vargas Ferreira, Ph.D

Role: backup

fernandaferreira@unipampa.edu.br

+55513359-8117

Other Identifiers

16-0235

Identifier Type: -

Identifier Source: org_study_id