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A Study to see the benefits of adding tablet letrozole to the usual extended cycle oral contraceptive pills in reduction of endometriosis related of pain.

A Prospective, open labelled, randomized interventional study to assess the effectiveness of Letrozole- an aromatase inhibitor in the medical management of Endometriosis. - LIME STUDY

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/08/027497
Enrollment
70
Registered
2020-08-31
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: - Health Condition 2: N809- Endometriosis, unspecified

Interventions

Intervention1: Oral Tablet Letrozole: People who participate after fulfilling inclusion and exclusion criteria in this study of treatment of endometriosis related pain , will be randomised into 2 grou

Sponsors

Internal Fluid Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Women in reproductive age group of 18 to 45years not planning on conceiving for next 6months and diagnosed with endometriosis. 2.Women who are planned for medical management and not for surgical management. 3.Women with pain score of more than or equal to seven in Numerical rating scale.

Exclusion criteria

Exclusion criteria: 1.Post menopausal women. 2.Women planning on conceiving in the next 6months. 3.Women who took therapies other than NSAIDs for 3months prior to inclusion in the study. 4.Previous use of aromatase inhibitors. 5.Women with osteoporosis or osteopenia. 6.Women with past or present history of seizure disorders, pulmonary, cardiac, hepatic or renal diseases.

Design outcomes

Primary

MeasureTime frame
To assess the effectiveness of Letrozole in the reduction of symptoms of pain using Numerical Rating Scale after six months of therapy in Women of reproductive age group between 18 years to 45 years.Timepoint: 6months

Secondary

MeasureTime frame
1.To assess the effectiveness of Letrozole in the reduction of endometrioma size using Ultrasound abdomen after six months of therapy in Women of reproductive age group between 18 years to 45 years. 2.To assess the effectiveness of Letrozole in the discription of menstrual cycle pattern by historical recall in OPD visit after six months of therapy in Women of reproductive age group between 18 years to 45 years.Timepoint: 6months

Countries

India

Contacts

Public ContactDr Vaibhav Londhe

Christian Medical College and Hospital Vellore

vlondz@cmcvellore.ac.in9566571074

Outcome results

None listed

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