Effects of Hormone Replacement Therapy on Arthralgia in Postmenopausal Women
Keywords
Abstract
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.
Dates
| Last Verified: | 12/31/2018 |
| First Submitted: | 06/08/2016 |
| Estimated Enrollment Submitted: | 07/14/2016 |
| First Posted: | 07/19/2016 |
| Last Update Submitted: | 10/10/2019 |
| Last Update Posted: | 10/13/2019 |
| Actual Study Start Date: | 02/28/2017 |
| Estimated Primary Completion Date: | 12/01/2019 |
| Estimated Study Completion Date: | 12/30/2020 |
Condition or disease
Intervention/treatment
Drug: Conjugated Equine Estrogen
Drug: Placebo
Phase
Arm Groups
| 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. |
| 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. |
Eligibility Criteria
| Ages Eligible for Study | 45 Years To 45 Years |
| Sexes Eligible for Study | Female |
| Accepts Healthy Volunteers | Yes |
| 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 |
Outcome
Primary Outcome Measures
1. Arthralgia [6 months]
Secondary Outcome Measures
1. Climacteric symptoms [6 months]
2. Level of physical activity [6 months]
3. Pain Catastrophizing [6 months]
4. Health-related quality of life [6 months]
5. Depression [6 months]
6. Anxiety [6 months]
7. Quality of sleep [6 months]
