Letrozole vs Danazol for Endometriosis-Related Pain: Randomized Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-10

Study Completion Date

2025-07-31

Brief Summary

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Background:

Endometriosis is a chronic gynecological condition defined by the ectopic presence of endometrial glands and stroma outside the uterine cavity, most commonly diagnosed via laparoscopy. While its exact etiology remains uncertain, a positive family history is considered a significant risk factor. Danazol has historically demonstrated efficacy in alleviating endometriosis-related pain, while letrozole, primarily used in neoadjuvant settings, has recently emerged as a promising alternative. This study aimed to compare the mean reduction in pain scores between letrozole and danazol in women with laparoscopically confirmed endometriosis.

Objective:

To compare the efficacy of letrozole versus danazol in reducing pain scores among women diagnosed with endometriosis.

Material \& Methods:

Study Design: Randomized control trial Setting: Department of Obstetrics \& Gynaecology, Sharif Medical and Dental Hospital

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Detailed Description

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Introduction:

Endometriosis is defined by the ectopic presence of functional endometrial glands and stroma outside the uterine cavity, most commonly diagnosed via direct laparoscopic visualization (1). Clinical manifestations include dysmenorrhea, dyspareunia, chronic pelvic pain, and infertility-each of which may significantly impair a woman's quality of life (2). It is a chronic, estrogen-dependent inflammatory condition predominantly affecting women of reproductive age, though adolescents may also be affected (3). Its true prevalence remains uncertain due to underdiagnosis and a diagnostic delay averaging nearly a decade, often attributed to normalization of symptoms and missed recognition by primary care providers. Beyond physical symptoms, endometriosis exerts a profound psychosocial and economic burden on affected individuals, their families, and healthcare systems globally (4).

Pathophysiology and Clinical Impact of Ectopic Endometrial Tissue in Endometriosis Ectopic endometrial tissue typically localizes in the dependent regions of the pelvis, such as the posterior and anterior cul-de-sac, uterosacral ligaments, ovaries, and fallopian tubes; however, extra-pelvic involvement is also possible (5). These implants respond to cyclic hormonal stimulation much like eutopic endometrium, undergoing phases of proliferation, secretion, and subsequent shedding. The metabolic by-products especially cytokines and prostaglandins foster a chronic inflammatory milieu characterized by neovascularization, fibrosis, and pain sensitization. Immunologic dysregulation is also implicated, including aberrant T- and B-cell responses, complement system activation, and elevated interleukin-6 (IL-6) levels in affected individuals. These immunoinflammatory mechanisms lead to adhesion formation, anatomic distortion, and chronic pelvic pain which are the hallmark features of the disease (5).

Classification of Endometriosis:

Endometriosis can be classified into three main types based on lesion location. Superficial peritoneal endometriosis is the most common form, characterized by lesions affecting the peritoneum, the thin membrane lining the pelvic cavity. Endometriomas, or ovarian lesions, are dark, fluid-filled cysts ("chocolate cysts") that develop within the ovaries, often resistant to treatment and capable of damaging healthy ovarian tissue. Deeply infiltrating endometriosis extends beneath the peritoneal surface and may involve adjacent pelvic organs such as the bowel or bladder, occurring in approximately 1% to 5% of affected women (6). (Figure 1).

Figure 1: An Illustration that is an overview of the three primary types of endometrioses based on lesion location: superficial peritoneal lesions, ovarian endometriomas, and deeply infiltrating endometriosis.

Comparative Evaluation of Letrozole and Danazol for Pain Reduction in Females with Endometriosis

Despite varied symptoms, endometriosis diagnosis is often delayed due to the absence of reliable non-invasive biomarkers. Current hormone therapies and analgesics offer limited long-term efficacy, as recurrence is common. Letrozole, an aromatase inhibitor, competitively binds to the cytochrome P450 subunit, reducing estrogen biosynthesis and offering a novel approach to managing endometriosis (7). Letrozole, an aromatase inhibitor, has demonstrated effectiveness in reducing endometriosis-related pain without recurrence post-treatment (8). Danazol, a synthetic androgen, suppresses ovarian activity and modulates immune function but has shown inconsistent results in pain management across studies (9). Although hormone therapies such as letrozole and danazol are widely used for symptom management, existing literature reports conflicting evidence regarding their effectiveness in reducing endometriosis-related pain. The present study seeks to answer the research question: "Among females diagnosed with endometriosis, how does the reduction in pain scores with letrozole therapy compare to danazol therapy over a three-month period, and which agent offers more consistent and sustained pain relief to inform standardized treatment protocols?" Addressing this question may improve patient outcomes in management of pain. So, this study aims to compare letrozole with danazol's impact on pain reduction in females with endometriosis, to guide future treatment protocols and update local clinical guidelines.

Conditions

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Endometriosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

This is a randomized, parallel-group trial with two treatment arms. Participants will be allocated to receive either Letrozole or Danazol for management of endometriosis-related pain. Each participant will remain in their assigned arm throughout the study period.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

This is an open-label study due to differences in drug formulations. Participants and investigators will know the assigned intervention; outcomes will be measured using validated patient-reported scales to reduce bias."

Study Groups

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Arm 1: Letrozole

Participants in this arm will receive Letrozole 2.5 mg orally once daily for 12 weeks for management of endometriosis-related pelvic pain.

Group Type EXPERIMENTAL

Letrozole

Intervention Type DRUG

Letrozole 2.5 mg orally once daily for 12 weeks.

Arm 2: Danazol

Participants in this arm will receive Danazol 200 mg orally twice daily for 12 weeks for management of endometriosis-related pelvic pain.

Group Type ACTIVE_COMPARATOR

danazol

Intervention Type DRUG

Danazol 200 mg orally twice daily for 12 weeks.

Interventions

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Letrozole

Letrozole 2.5 mg orally once daily for 12 weeks.

Intervention Type DRUG

danazol

Danazol 200 mg orally twice daily for 12 weeks.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Women aged 18-45 years

Surgically or clinically diagnosed endometriosis

Moderate to severe pelvic pain (NRS ≥ 4 for at least 3 months)

Willing to use effective contraception during the study

Able to provide informed consent

Exclusion Criteria

* Pregnant or breastfeeding

Severe hepatic disease, thromboembolic disorder, or contraindication to study drugs

Use of hormonal therapy within the last 8 weeks

Known hypersensitivity to Letrozole or Danazol

Participation in another clinical trial within the last 3 months

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No