ArthralgiaPhase 2NCT02838576
Effects of Hormone Replacement Therapy on Arthralgia in Postmenopausal Women
A Phase 2 study testing Conjugated Equine Estrogen in people with Arthralgia, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 45 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Arthralgia
- What is being tested?
- Conjugated Equine Estrogen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2017to 31 Dec 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Comitê de Ética em Pesquisa do Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul
Maria Celeste Osório Wender, Ph.D, +55513359-8117, mceleste@ufrgs.br
Fernanda Vargas Ferreira, Ph.D, +55513359-8117, fernandaferreira@unipampa.edu.br
About this study
Official title: Effects of Hormone Replacement Therapy on Arthralgia in Postmenopausal Women: a Randomized, Double-blind Controlled Trial
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.
Read the 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.
- Conditions
- Arthralgia
- Being tested
- Conjugated Equine Estrogen, Placebo
- Medical subject headings
- Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conjugated Equine EstrogenDrug
Also called Drug active
Use of conjugated equine estrogen for 12 weeks. Adherence will be monitored during periodical hospital visits in order to receive pills.
PlaceboDrug
Use of placebo for 12 weeks. Adherence will be monitored during periodical hospital visits in order to receive pills.
| Study group | Role | What they receive |
|---|---|---|
| Conjugated Equine Estrogen | Experimental | 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. Receives: Drug: Conjugated Equine Estrogen |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arthralgia
Arthralgia´ll be measured by numeric scale (0-10).
Measured: 6 months
Secondary outcomes (7)
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
Depression
Depression´ll be evaluated by Beck Depression Inventory - Brazilian Version. The standard cut-off scores are minimal, mild, moderate and severe depression.
Measured: 6 months
Anxiety
Anxiety´ll be evaluated by Beck Anxiety Inventory - Brazilian Version. The standard cut-off scores are minimal, mild, moderate and severe depression.
Measured: 6 months
Quality of sleep
Quality of sleep´ll be evaluated by Pittsburgh Sleep Quality Index - Brazilian Version. Lower scores denote a healthier sleep quality.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study start1 Mar 2017
- Primary completion2 Dec 2019 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthralgiaStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Celeste Osório Wender, Ph.D, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02838576
- Sponsor's protocol ID
- 16-0235
- Status last verified
- Jan 2019
- First submitted
- 9 Jun 2016
- Last updated
- 14 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hormone Replacement Therapy on Arthralgia in Postmenopausal Women: a Randomized, Double-blind Controlled Trial
- ClinicalTrials.gov ID
- NCT02838576
- Acronym / sponsor ID
- 16-0235
- Conditions
- Arthralgia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 2 Dec 2019 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 20 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conjugated Equine Estrogen | Experimental | Drug: Conjugated Equine EstrogenThirty-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. |
| Placebo | Placebo comparator | Drug: PlaceboThirty-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. |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conjugated Equine EstrogenAlso: Drug activeUse of conjugated equine estrogen for 12 weeks. Adherence will be monitored during periodical hospital visits in order to receive pills. | Drug | Conjugated Equine Estrogen |
| PlaceboUse of placebo for 12 weeks. Adherence will be monitored during periodical hospital visits in order to receive pills. | Drug | Placebo |
Primary outcome
Arthralgia
Time frame: 6 months
Arthralgia´ll be measured by numeric scale (0-10).
7 secondary outcomes
Climacteric symptoms
Time frame: 6 months
Level of physical activity
Time frame: 6 months
Pain Catastrophizing
Time frame: 6 months
Health-related quality of life
Time frame: 6 months
Depression
Time frame: 6 months
Anxiety
Time frame: 6 months
Quality of sleep
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Celeste Osório Wender, Ph.D principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Conjugated Equine Estrogen in people with Arthralgia, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Celeste Osório Wender, Ph.D (55 51 3359-8117, mceleste@ufrgs.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arthralgia (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2019.