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A clinical trial to study the effects of two drugs, ormeloxifene and Norethisterone acetate in patients with abnormal uterine bleeding

Effectiveness of Ormeloxifene versus Norethisterone acetate for control of bleeding in women with abnormal uterine bleeding– A randomized control trial. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/12/078353
Enrollment
60
Registered
2024-12-19
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Health Condition 1: E289- Ovarian dysfunction, unspecified

Interventions

Control Intervention1: Norethisterone: 5mg per oral BD 21 days for 6 menstrual cycles Control Intervention2: Ormeloxifene: 60mg per oral twice a week for 12 weeks followed by once a week for 12 weeks

Sponsors

Vasundhara Wasudeo Gawande
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: women willing to keep record of vaginal bleeding and regular follow up

Exclusion criteria

Exclusion criteria: PCOS, postmenopausal bleeding, heart disease, genital malignancy, puberty menorrhagia

Design outcomes

Primary

MeasureTime frame
endometrial thickness, blood loss in terms of PBACTimepoint: 1month, 3month, 6month—

Secondary

MeasureTime frame
oligomenorrhea, hypomenrrhea, weight gain, nausea, vomitingTimepoint: 1month—

Countries

India

Contacts

Public ContactVasundhara Wasudeo Gawande

NKP SALVE INSTITUE OF MEDICAL SCIENCES AND RESEARCH CENTRE, NAGPUR

varshadkose@gmail.com9372304330

Outcome results

None listed

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