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Ormeloxifene: a better therapeutic option than Medroxyprogesterone Acetate in perimenopausal women with abnormal uterine bleeding.

Comparative study of Ormeloxifene versus Medroxyprogesterone Acetate in abnormal uterine bleeding in perimenopausal women

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/09/021275
Enrollment
62
Registered
2019-09-17
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: N920- Excessive and frequent menstruation with regular cycle

Interventions

Intervention1: Ormeloxifene: 3rd generation SERM (Selective Estrogen Receptor Modulator). Non steroidal Non Hormonal OCP. Ormeloxifene will be given in the dose of 60mg twice a week for 3 months, fol

Sponsors

Nivedita Chawla
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All perimenopausal females between the age of 39 to 51 years with abnormal uterine bleeding.

Exclusion criteria

Exclusion criteria: a. Pregnancy b. Organic Pelvic Pathology like polyp, fibroid, adenomyosis, endometriosis c. Systemic Pathology d. Coagulation disorders e. Breast malignancy f. Endometrial Hyperplasia with atypia g. Endocrine disorders like hypothyroidism

Design outcomes

Primary

MeasureTime frame
To compare the effectiveness of Ormeloxifene vs Medroxyprogesterone Acetate in cases of abnormal uterine bleeding in perimenopausal women.Timepoint: Follow up will be done at 2nd month, 4th month and 6th month

Secondary

MeasureTime frame
â?¢To study the effectiveness of Ormeloxifene in AUB in perimenopausal women. â?¢To study the effectiveness of Medroxyprogesterone Acetate in AUB in perimenopausal women. â?¢To compare Ormeloxifene versus Medroxyprogesterone Acetate in terms of PBAC Score, endometrial thickness by TVS, rise in haemoglobin and hematocrit AUB in perimenopausal women. At 2nd month symptomatic improvement, PBAC score and side effects will be assessed.Timepoint: 2nd, 4th and 6th month.

Countries

India

Contacts

Public ContactDr Rehana Najam

Teerthanker Mahaveer Medical College

rehananajam01@gmail.com9837291920

Outcome results

None listed

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