Effects of Hormone Replacement Therapy on Arthralgia in Postmenopausal Women: a Randomized, Double-blind Controlled Trial
Trial Snapshot
- Phase
- Phase 2
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Arthralgia
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 45 Years to 55 Years (Adult)
- Sex
- 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
- •abuse of alcohol and drugs
- •large surgeries
Arms & Interventions
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.
Intervention: Conjugated Equine Estrogen (Drug)
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.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Arthralgia
Time Frame: 6 months
Arthralgia´ll be measured by numeric scale (0-10).
Secondary Outcomes
- Level of physical activity(6 months)
- Depression(6 months)
- Quality of sleep(6 months)
- Climacteric symptoms(6 months)
- Health-related quality of life(6 months)
- Pain Catastrophizing(6 months)
- Anxiety(6 months)