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camparative study of safety and efficacy of Medroxyprogesterone acetate and ormeloxifene in women with Abnormal uterine bleeding: An observational study

PROSPECTIVE OBSERVATIONAL STUDY FOR SAFETY & EFFICACY OF ORMELOXIFENE & MEDROXYPROGESTERONE ACETATE IN WOMEN WITH ABNORMAL UTERINE BLEEDING

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2019/01/017230
Enrollment
240
Registered
2019-01-24
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: N00-N99- Diseases of the genitourinary system

Interventions

Control Intervention1: Ormeloxifene and medroxyprogesterone acetate: Dose and frequency of ormeloxifene is 60mg twice a week for three months, dose and frequency of medroxyprogesterone acetate is 10m

Sponsors

SKIMS Medical College and Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All patients diagnosed with AUB attending the OPD/or for consultation in the Obstetrics and Gynaecology department of SKIMS Medical College and Hospital, Bemina, Srinagar will be enrolled during the study period

Exclusion criteria

Exclusion criteria: Patients with leiomyoma, adenomyosis, polyp, adnexal mass. Patients with systemic disorder. Patients with coagulopathy Patients with breast malignancy Patients with endometrial hyperplasia

Design outcomes

Primary

MeasureTime frame
to compare the effects of ormeloxifene and medroxyprogesterone acetate in womenn with abnormal uterine bleeding on Heamoglobon, Endometrail thickness and Pictorial blood loss assessment by Complete blood chemistry, USG and PBAC score card respectivelyTimepoint: AFTER 4 MONTHS

Secondary

MeasureTime frame
to compare the effects of ormeloxifene and medroxyprogesterone acetate in womenn with abnormal uterine bleeding on Heamoglobon, Endometrail thickness and Pictorial blood loss assessment by Complete blood chemistry, USG and PBAC score card respectivelyTimepoint: monthly follow up upto 4 months

Countries

India

Contacts

Public ContactSuhail Ahmad Mir

university of kashmir

gbader2007@gmail.com7006224042

Outcome results

None listed

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