Effects of Hormone Replacement Therapy on Arthralgia in Postmenopausal Women

Sponsor

Hospital de Clinicas de Porto Alegre (Other)

Overall Status

Unknown status

CT.gov ID

NCT02838576

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Arthralgia	Drug: Conjugated Equine Estrogen Drug: Placebo	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Effects of Hormone Replacement Therapy on Arthralgia in Postmenopausal Women: a Randomized, Double-blind Controlled Trial

Actual Study Start Date :

Mar 1, 2017

Anticipated Primary Completion Date :

Dec 2, 2019

Anticipated Study Completion Date :

Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Conjugated Equine Estrogen Use of conjugated equine estrogen for 12 weeks. Adherence will be monitored during periodical hospital visits in order to receive pills. Other Names: Drug active
Placebo Comparator: 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.	Drug: Placebo Use of placebo for 12 weeks. Adherence will be monitored during periodical hospital visits in order to receive pills.

Arm

Intervention/Treatment

Experimental: 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.

Drug: Conjugated Equine Estrogen

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

Other Names:

Drug active

Placebo Comparator: 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.

Drug: Placebo

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

Outcome Measures

Primary Outcome Measures

Arthralgia [6 months]
Arthralgia´ll be measured by numeric scale (0-10).

Secondary Outcome Measures

Climacteric symptoms [6 months]
Climacteric symptoms´ll be evaluated by Menopause Rating Scale - Brazilian Version. The score increases point by point with increasing severity of subjectively perceived symptoms in each of the 11 items.
Level of physical activity [6 months]
Level of physical activity´ll be evaluated by International Physical Activity Questionnaire - Brazilian Version whose three levels of physical activity are low, moderate and high.
Pain Catastrophizing [6 months]
Pain Catastrophizing´ll be evaluated by Pain Catastrophizing - Brazilian Version into three subscales being magnification, rumination, and helplessness. The higher the score, the more catastrophizing thoughts are present.
Health-related quality of life [6 months]
Quality of life´ll be evaluated by Women´s Health Questionnaire - Brazilian Version (somatic symptoms, depressed mood, cognitive difficulties, anxiety and fear, sexual functioning, vasomotor symptoms, sleep problems, menstrual problems, and self-perceived attraction). The higher the score, the more pronounced the suffering and dysfunction.
Depression [6 months]
Depression´ll be evaluated by Beck Depression Inventory - Brazilian Version. The standard cut-off scores are minimal, mild, moderate and severe depression.
Anxiety [6 months]
Anxiety´ll be evaluated by Beck Anxiety Inventory - Brazilian Version. The standard cut-off scores are minimal, mild, moderate and severe depression.
Quality of sleep [6 months]
Quality of sleep´ll be evaluated by Pittsburgh Sleep Quality Index - Brazilian Version. Lower scores denote a healthier sleep quality.

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 55 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Comitê de Ética em Pesquisa do Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande Do Sul	Brazil

Sponsors and Collaborators

Hospital de Clinicas de Porto Alegre

Investigators

Principal Investigator: Maria Celeste Osório Wender, Ph.D, Hospital de Clínicas de Porto Alegre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hospital de Clinicas de Porto Alegre

ClinicalTrials.gov Identifier:

NCT02838576

Other Study ID Numbers:

16-0235

First Posted:

Jul 20, 2016

Last Update Posted:

Oct 14, 2019

Last Verified:

Jan 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Arthralgia

Estrogens

Estrogens, Conjugated (USP)

Study Results

No Results Posted as of Oct 14, 2019