Effects of Hormone Replacement Therapy on Arthralgia in Postmenopausal Women

Arthralgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02838576
• Other study ID #: 16-0235
• Status: Recruiting
• Phase: Phase 2
• Start date: March 1, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2019
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Maria Celeste Osório Wender, Ph.D
• Phone: 55 51 3359-8117
• Email: mceleste[@]ufrgs.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: December 31, 2020
• Est. primary completion date: December 2, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthralgia

Intervention

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

Locations

Country	Name	City	State
Brazil	Comitê de Ética em Pesquisa do Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arthralgia	Arthralgia´ll be measured by numeric scale (0-10).	6 months
Secondary	Climacteric symptoms	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.	6 months
Secondary	Level of physical activity	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.	6 months
Secondary	Pain Catastrophizing	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.	6 months
Secondary	Health-related quality of life	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.	6 months
Secondary	Depression	Depression´ll be evaluated by Beck Depression Inventory - Brazilian Version. The standard cut-off scores are minimal, mild, moderate and severe depression.	6 months
Secondary	Anxiety	Anxiety´ll be evaluated by Beck Anxiety Inventory - Brazilian Version. The standard cut-off scores are minimal, mild, moderate and severe depression.	6 months
Secondary	Quality of sleep	Quality of sleep´ll be evaluated by Pittsburgh Sleep Quality Index - Brazilian Version. Lower scores denote a healthier sleep quality.	6 months