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Can we Use Estrogen-containing Therapy to Improve Pain in Women After Menopause With Hand Osteoarthritis? | Clinical Trials | Clareo Health

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Can we Use Estrogen-containing Therapy to Improve Pain in Women After Menopause With Hand Osteoarthritis?

Hand Osteoarthritis: Investigating Pain Effects in a Randomised Placebo-controlled Feasibility Study of an Estrogen-containing Therapy

NCT04036929•University of Oxford

View on ClinicalTrials.gov

Summary

Post-menopausal women aged 40-65 with symptomatic hand osteoarthritis are invited to take part in this feasibility study. The study's aim is to investigate whether it is acceptable to women with painful hand OA to take an estrogen-containing therapy, and what is the best way of collecting some of the information in order to facilitate planning a full size trial. The investigator's long-term aim is to find out whether giving estrogen-containing therapy to women after the menopause improves hand OA symptoms.

Eligibility

Age

40 - 65 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Able to give informed written consent
•Female, aged 40-65 years old
•In those with an intact uterus: At least 12 months of spontaneous amenorrhea (without any menstrual bleeding in last 12 months) and last menstrual period not more than 10 years ago
•In those who have undergone hysterectomy or are/were using an intrauterine contraceptive device with progesterone local therapy (such as Mirena): Follicle stimulating hormone (FSH) ≥30 milli-International Units per millilitre (mIU/ml) on screening blood test AND a history of menopausal symptoms in the last 1 to 10 years, in keeping with appropriate timing of menopausal status
•Hand pain, aching or stiffness on most days in the last 3 months
•At least 2, painful hand joints of any type (interphalangeal joints (IPJ) or base of thumbs)
•Fulfils American College of Rheumatology clinical diagnostic criteria for hand OA (3 or more of following):
•1. Hard tissue enlargement of 2 or more of the following joints: 2nd or 3rd distal interphalangeal joints (DIPJ), 2nd or 3rd proximal interphalangeal joints (PIPJ), first carpometacarpal joints (CMCJ)
•2. Hard tissue enlargement of 2 or more of the DIPJs
•3. Less than 3 swollen metacarpophalangeal joints (MCPJ)
+5 more criteria

Exclusion Criteria

•Other cause of hand pain, including inflammatory arthritis, connective tissue disorder, chronic pain or alternative clinical diagnosis such as tenosynovitis or carpal tunnel syndrome
•Pregnancy or breast feeding, or risk of this during study
•Use of one or more prohibited treatments within specified timeframe, or not willing to avoid treatment for the duration of the study:
•* Oral contraceptive pill, or systemic HRT within the last 6 months (Use of an intrauterine contraceptive device with progesterone local therapy (Mirena) or vaginal topical estrogen use (known low systemic absorption) are not exclusions to participation)
•* Anti-estrogen medication within the last 6 months
•* Oral, intramuscular or intraarticular steroid within the last 3 months
•* Intraarticular hyaluronan to a hand joint within the last 6 months
•* Initiation of new oral analgesia within the last 4 weeks
•* Initiation of glucosamine, chondroitin, hand exercises or other relevant non- pharmacological therapy within the last 6 weeks
•* Hand surgery within the last 6 months, or planned within the next 6 months
+24 more criteria

Locations (3)

White Horse Medical Practice, Faringdon Medical Centre

Faringdon, Oxfordshire, United Kingdom

Charing Cross Hospital, Imperial College Healthcare NHS Trust

London, United Kingdom

Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom

Key Dates

Start Date

May 9, 2019

Primary Completion Date

August 19, 2021

Completion Date

December 10, 2021

Last Updated

April 21, 2022

Enrollment

ACTUAL participants

Conditions

Hand Osteoarthritis

Interventions

Estrogen-bazedoxifene

DRUG

Placebo oral tablet

DRUG

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ACTIVE_NOT_RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 21, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Can we Use Estrogen-containing Therapy to Improve Pain in Women After Menopause With Hand Osteoarthritis?

Inclusion Criteria

Exclusion Criteria

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