Clinical trial NCT02838576: Effects of Hormone Replacement Therapy on Arthralgia in Postmenopausal Women
Official title: Effects of Hormone Replacement Therapy on Arthralgia in Postmenopausal Women: a Randomized, Double-blind Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Arthralgia
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2016-07-20
Enrollment: 72
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Arthralgia
timeFrame: 6 months
Secondary outcomes:
measure: Climacteric symptoms
timeFrame: 6 months
measure: Level of physical activity
timeFrame: 6 months
measure: Pain Catastrophizing
timeFrame: 6 months
measure: Health-related quality of life
timeFrame: 6 months
measure: Depression
timeFrame: 6 months
measure: Anxiety
timeFrame: 6 months
measure: Quality of sleep
timeFrame: 6 months
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Comitê de Ética em Pesquisa do Hospital de Clínicas de Porto Alegre
state: Rio Grande Do Sul
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Maria Celeste Osório Wender, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: