Osteoarthritis in Postmenopausal WomenPhase 3NCT07395895
Effect of Metformin Iontophoresis on Knee Osteoarthritis in Postmenopausal Women
A Phase 3 study testing Metformin gel Iontophoresis and Iontophoresis in people with Osteoarthritis in Postmenopausal Women, run by Badr University at 1 site in Egypt.
Trial summary
This study is designed as a randomized, double-blind, placebo-controlled clinical trial with two parallel groups. All participants will receive a standardized physical therapy rehabilitation program. Read more about this study
- Who is it for?
- Ages 50 to 70 years, women only
- Conditions the study is for
- Osteoarthritis in Postmenopausal Women
- What is being tested?
- Metformin gel Iontophoresis and Iontophoresis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2026to 1 May 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 50 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Postmenopausal women aged 50-70 years.
- Clinical and radiographic diagnosis of knee osteoarthritis according to the American College of Rheumatology criteria.
- Radiographic severity classified as Kellgren-Lawrence grade II or III.
- Chronic knee pain for a duration of at least 3 months.
- Pain intensity ≥4 on the Visual Analog Scale.
- Ability to ambulate independently with or without assistive devices.
- Ability to understand and follow instructions.
- Willingness to participate and provide written informed consent.
Who cannot join
- • Severe knee osteoarthritis (Kellgren-Lawrence grade IV).
- History of knee surgery or intra-articular injections within the previous 6 months.
- Presence of inflammatory rheumatic diseases such as rheumatoid arthritis or gout.
- Neurological disorders affecting lower limb function.
- Uncontrolled metabolic, cardiovascular, or systemic diseases.
- Current or recent use of metformin or other antidiabetic medications.
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- Skin lesions, infections, or hypersensitivity at the iontophoresis site.
- Contraindications to electrotherapy such as pacemakers or implanted electronic devices.
- Body mass index ≥35 kg/m².
- Participation in another clinical trial within the last 3 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Badr University in Cairo
Cairo, 11829
Eman Sawan, PH D, 01090111013, eman.said@buc.edu.eg
About this study
Official title: Effect of Metformin Iontophoresis Combined With Physical Therapy Rehabilitation on Knee Osteoarthritis in Postmenopausal Women: A Randomized Double-Blind Placebo-Controlled Clinical Trial
This study is designed as a randomized, double-blind, placebo-controlled clinical trial with two parallel groups. All participants will receive a standardized physical therapy rehabilitation program. Participants will be randomly allocated into either a study group receiving metformin iontophoresis or a control group receiving placebo iontophoresis. Both participants and outcome assessors will be blinded to group allocation.
Read the detailed description
The study population will consist of postmenopausal women diagnosed with knee osteoarthritis. Postmenopause is defined as the absence of menstruation for at least 12 consecutive months. Participants will be randomly assigned to either the study or control group using a computer-generated randomization sequence. Allocation concealment will be ensured using sealed opaque envelopes. Both participants and outcome assessors will be blinded to the treatment allocation. The physical therapist applying iontophoresis will not be involved in outcome assessment.
- Conditions
- Osteoarthritis in Postmenopausal Women
- Being tested
- Metformin gel Iontophoresis, Iontophoresis
- Keywords
- Metformin gel, Iontophoresis, Physical Therapy Rehabilitation, Osteoarthritis, Postmenopausal Women
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin gel IontophoresisDrug
Metformin gel 2% Iontophoresis Combined with Physical Therapy Rehabilitation
IontophoresisDevice
Iontophoresis with neutral gel Combined with Physical Therapy Rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Metformin Iontophoresis | Active comparator | Not described Receives: Drug: Metformin gel Iontophoresis |
| Iontophoresis Combined with Physical Therapy Rehabilitation | Active comparator | Not described Receives: Device: Iontophoresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
assessed using the Visual Analog Scale.
Measured: at baseline, after 6 weeks and after 12 weeks
Functional status
assessed using the WOMAC index
Measured: at baseline, after 6 weeks and after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion15 Apr 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis in Postmenopausal WomenStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Badr University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Said Sawan, Badr University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07395895
- Sponsor's protocol ID
- IRB00014233-66
- Status last verified
- Feb 2026
- First submitted
- 1 Feb 2026
- Last updated
- 9 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
1. Bannuru RR, Osani MC, Vaysbrot EE, et al. OARSI guidelines for the non-surgical management of knee osteoarthritis. Osteoarthritis and Cartilage. 2019;27(11):1578-1589. 2. Kolasinski SL, Neogi T, Hochberg MC, et al. 2020 American College of Rheumatology guideline for the management of osteoarthritis of the hand, hip, and knee. Arthritis Care & Research. 2020;72(2):149-162. 3. Quicke JG, Foster NE, Ogollah RO, et al. Supervised exercise therapy for knee osteoarthritis: A randomized controlled trial. Ann Rheum Dis. 2022;81(3):336-343. 4. Wang Y, Hussain SM, Wluka AE, et al. Effect of exercise therapy on knee osteoarthritis: Systematic review and meta-analysis. Arthritis Res Ther. 2021;23:147. 5. Zhang W, Doherty M, Peat G, et al. EULAR evidence-based recommendations for knee osteoarthritis management. Ann Rheum Dis. 2020;79(6):685-699.
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Metformin Iontophoresis Combined With Physical Therapy Rehabilitation on Knee Osteoarthritis in Postmenopausal Women: A Randomized Double-Blind Placebo-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07395895
- Acronym / sponsor ID
- IRB00014233-66
- Conditions
- Osteoarthritis in Postmenopausal Women
- Keywords
- Metformin gel, Iontophoresis, Physical Therapy Rehabilitation, Osteoarthritis, Postmenopausal Women
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Badr UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 15 Apr 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 9 Feb 2026 (actual)
- 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.
This study is designed as a randomized, double-blind, placebo-controlled clinical trial with two parallel groups. All participants will receive a standardized physical therapy rehabilitation program. Participants will be randomly allocated into either a study group receiving metformin iontophoresis or a control group receiving placebo iontophoresis. Both participants and outcome assessors will be blinded to group allocation.
Detailed description
The study population will consist of postmenopausal women diagnosed with knee osteoarthritis. Postmenopause is defined as the absence of menstruation for at least 12 consecutive months. Participants will be randomly assigned to either the study or control group using a computer-generated randomization sequence. Allocation concealment will be ensured using sealed opaque envelopes. Both participants and outcome assessors will be blinded to the treatment allocation. The physical therapist applying iontophoresis will not be involved in outcome assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin Iontophoresis | Active comparator | Drug: Metformin gel Iontophoresis |
| Iontophoresis Combined with Physical Therapy Rehabilitation | Active comparator | Device: Iontophoresis |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- • Postmenopausal women aged 50-70 years.
Key exclusion criteria (10 listed)
- • Severe knee osteoarthritis (Kellgren-Lawrence grade IV).
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 |
|---|---|---|
| Metformin gel IontophoresisMetformin gel 2% Iontophoresis Combined with Physical Therapy Rehabilitation | Drug | Metformin Iontophoresis |
| IontophoresisIontophoresis with neutral gel Combined with Physical Therapy Rehabilitation | Device | Iontophoresis Combined with Physical Therapy Rehabilitation |
Primary outcome
Pain intensity
Time frame: at baseline, after 6 weeks and after 12 weeks
assessed using the Visual Analog Scale.
Functional status
Time frame: at baseline, after 6 weeks and after 12 weeks
assessed using the WOMAC index
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Background1. Bannuru RR, Osani MC, Vaysbrot EE, et al. OARSI guidelines for the non-surgical management of knee osteoarthritis. Osteoarthritis and Cartilage. 2019;27(11):1578-1589. 2. Kolasinski SL, Neogi T, Hochberg MC, et al. 2020 American College of Rheumatology guideline for the management of osteoarthritis of the hand, hip, and knee. Arthritis Care & Research. 2020;72(2):149-162. 3. Quicke JG, Foster NE, Ogollah RO, et al. Supervised exercise therapy for knee osteoarthritis: A randomized controlled trial. Ann Rheum Dis. 2022;81(3):336-343. 4. Wang Y, Hussain SM, Wluka AE, et al. Effect of exercise therapy on knee osteoarthritis: Systematic review and meta-analysis. Arthritis Res Ther. 2021;23:147. 5. Zhang W, Doherty M, Peat G, et al. EULAR evidence-based recommendations for knee osteoarthritis management. Ann Rheum Dis. 2020;79(6):685-699.
- Individual participant dataSharing planned: No
Related trials for Osteoarthritis in Postmenopausal Women
RecruitingObservational study
Cartilage Biomarker Response to Acute Mechanical Loading in Women With Knee Osteoarthritis: Comparison by Antiresorptive Treatment Status
Knee Osteoarthritis
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Metformin gel Iontophoresis and Iontophoresis in people with Osteoarthritis in Postmenopausal Women, run by Badr University at 1 site in Egypt.
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 10 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: opening soon, as of the sponsor's last update on 9 Feb 2026. 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 Egypt. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eman swan, Ph d (+201090111013, eman.said@buc.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: at baseline, after 6 weeks and after 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07395895, which also lists 1 linked publication.
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 9 Feb 2026.