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Comparing two drugs for a treatment

Comparison of the effectiveness of depo-medroxyprogesterone (DMPA)+Atorvastatin (combination) Vs DMPA in the treatment of adenomyosis - NIL

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/03/064357
Enrollment
60
Registered
2024-03-18
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O998- Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium

Interventions

Intervention1: DMPA + Atorvastatin: DMPA - 150mg (IM) once in 3 months, Atorvastatin: 20 mg once daily Control Intervention1: Comparing DMPA + Atorvastatin in the treatment of adenomyosis with DMPA: S

Sponsors

SRM college of pharamacy
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: patients diagnosed with adenomyosis in ultrasonography patients willing to participate patient willing to be on contraceptives during study period

Exclusion criteria

Exclusion criteria: patients planning for pregnancy pregnant and lactating patients patients with mental illness patients who are already in any other hormonal treatment for adenomyosis patients who have undergone surgery (less than 6 months) patients diagnosed with mild hepatic dysfunction

Design outcomes

Primary

MeasureTime frame
To assess the change in pain as measured by Wong Bakers FACES pain rating scale in patients receiving DMPA + Atorvastatin and DMPA alone To assess the change in abnormal uterine bleeding as measured by the UFS-QOL questionnaire in patients receiving DMPA + Atorvastatin and DMPA aloneTimepoint: Patients will be followed at the end of 4, 8 and 12 weeks

Secondary

MeasureTime frame
To assess the change in uterine volume and vascularity by measuring the pulsatility index by transvaginal USG (MUSA criteria) To assess the quality of life in patients using UFS-QOL questionnaire To assess the Hb level on day 2 as measured by blood samples in patients with adenomyosis Timepoint: Patients will be followed at the end of 4, 8 and 12 weeks

Countries

India

Contacts

Public ContactSK NITHYASHREE

SRM INSTITUTION

srirama1@gmail.com8012345507

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026