TO ASSESS THE RELIEF OF SYMPTOMS LIKE BLOOD LOSS,ABDOMINAL PAIN AND ASSOCIATED SYMPTOMS IN PATIENTS DIAGNOSED WITH ADENOMYOSIS AFTER USING THE DRUG ORMELOXIFENE FOR 6 MONTHS

ORMELOXIFENE IN SYMPTOMATIC RELIEF OF ABNORMAL UTERINE BLEEDING-ADENOMYOSIS (AUB-A)-A LONGITUDINAL INTERVENTIONAL STUDY - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/12/060676

Enrollment

Registered

2023-12-22

Start date

Unknown

Completion date

Unknown

Last updated

2024-01-22

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

Conditions

Health Condition 1: N921- Excessive and frequent menstruation with irregular cycle

Interventions

Intervention1: ORMELOXIFENE: ORMELOXIFENE IS GIVEN TO THEM BIWEEKLY FOR 12 WEEKS AND THEN WEEKLY FOR NEXT 12 WEEKS. Control Intervention1: BEFORE START OF ORMELOXIFENE: THE SEVERITY OF SYMPTOMS OF ADE

Eligibility

Inclusion criteria

Inclusion criteria: 1)Patients with adenomyosis with heavy menstrual bleeding and/or dysmenorrhea, dyspareunia 2)women > 25 years who have completed family

Exclusion criteria

Exclusion criteria: 1)Associated pelvic pathology like fibroid, endometriosis, malignancy 2)contra indications to Ormeloxifene like PCOS, renal impairment, liver impairment, recent h/o jaundice, pregnancy, lactation, hypersensitivity 3)chronic pelvic pain

Design outcomes

Primary

Measure	Time frame
To assess menstrual flow volume, dysmenorrhea, and quality of life after 3 and 6 months of using OrmeloxifeneTimepoint: 0,3,6 months	—

Secondary

Measure	Time frame
To assess side effects of the drug and failure rates.Timepoint: 0,3,6 months	—

Countries

India

Contacts

Public ContactDr Sivani Bodapati

JIPMER

ns.drkubera@gmail.com8825633402

Outcome results

None listed

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