A clinical study to determine the effects of oral medication ormeloxifene and Intrauterine device LNG-IUS (a small T shaped device that is placed inside the uterus) in women of age 18 to 45 years with uterine fibroids in reducing heavy menstrual bleeding, pain during menses and pain during menses

Comparison of efficacy of ormeloxifene (centchroman) and levonorgestrel intrauterine system in treatment of uterine leiomyoma in women of reproductive age group: A randomized controlled trial - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/09/094233

Enrollment

284

Registered

2025-09-04

Start date

Unknown

Completion date

Unknown

Last updated

2025-09-15

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

Conditions

Health Condition 1: D25- Leiomyoma of uterus

Interventions

Intervention1: Ormeloxifene: Ormeloxifene, or centchroman, a selective estrogen receptor modulator(SERM), is a non steroidal chemical with weak estrogenic and prominent anti-estrogenic activity and mi

Eligibility

Inclusion criteria

Inclusion criteria: Women presenting with complaint of heavy menstrual bleeding, with or without dysmenorrhea. Women detected to have uterine leiomyoma(AUB-L)- Upto 3 in number of size up to 5 cm each and FIGO stage 2-6, on transvaginal/transabdominal ultrasonography. Women giving informed consent.

Exclusion criteria

Exclusion criteria: Known or suspected pregnancy. Unexplained uterine bleeding. Acute pelvic inflammatory disease (PID). Uterus more than 12 weeks size. Bleeding disorders or coagulopathies or receiving anticoagulants. Contraindication to LNG-IUS or ormeloxifene.

Design outcomes

Primary

Measure	Time frame
Reduction in Menstrual blood loss (MBL) as per Pictorial Blood Assessment Chart (PBAC)Timepoint: 3 months	—

Secondary

Measure	Time frame
Improvement in dysmenorrhea as indicated on Visual Analogue Scale(VAS)Timepoint: 3 months;Decrease in total volume of leiomyoma(s) on transvaginal/transabdominal ultrasonographyTimepoint: 3 months;Adverse effects as reported by participantTimepoint: 3 months	—

Countries

India

Contacts

Public ContactRadhika Chandra

All India Institute of Medical Sciences, Raebareli

apalapriyadarshini@gmail.com

Outcome results

None listed

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