Comparison of Dienogest alone versus Dienogest and Ethinyl Estradiol for Endometriosis Pain Relief: an open label Randomized controlled Trial.

Introduction:

Endometriosis is the presence of endometrial glands & stroma outside the uterine cavity. It affects approximately 10% of women of reproductive age with significant impact on physical, mental, and social well-being. The main symptoms include pain, infertility and adnexal mass with the pain symptoms being dysmenorrhea, dyspareunia and chronic pelvic pain. The primary concern of treatment is to reduce the pain symptoms of endometriosis. There are various medical treatment options available including nonspecific non-steroidal anti-inflammatory drugs (NSAIDs), combined oral contraceptives (COC). Recent guidelines recommend the use of either COCs or progestins as a first-line medical treatment for pain associated with endometriosis. There is ample evidence supporting the efficacy in pain control and in reducing the risk of recurrence with both drugs. With the introduction of fourth generation progestins, Dienogest- a synthetic 19-norprogestins with a selective progestin effect the evidences showed extensive improvement in the pain symptoms. It also has anti-estrogenic, anti-gonadotropic, and anti-mineralocorticoid, and antiproliferative effects. Several studies have shown a significant improvement in pain symptoms following treatment with Dienogest. However, regarding the improvement in the pain symptoms there are no comparative study till date about the efficacy in pain relief.

Objectives:

To compare the efficacy in pain relief with Dienogest alone and combination of Dienogest and Ethinyl Estradiol in women with endometriosis.

Methods and materials:

An open-label, randomized, single center, 24-week comparative trial in women between the age of 20-45 years with clinically, radiologically or histologically confirmed endometriosis. Efficacy will be assessed by change in the Visual Analogue Score (VAS) for pain at the end of 12 week and 24 weeks. The other parameters will be assessed are change in the size of endometrioma, self-reported Biberoglu and Behrman (B&B) scale score for pain symptoms of endometriosis, and Improvement in the quality of life by Endometriosis Health Profile-30 (EHP-30) questionnaire. Any additional medications or treatment required for either pain or bleeding will be noted.

Results:

We will be expecting improvement in the primary and secondary outcome with Dienogest alone or combination of Dienogest and Ethinyl Estradiol. The tolerability and side effects with both drugs will also be assessed.

Conclusion:

Dienogest at 2 mg once a day for 84 days or combination of Dienogest 2mg and Ethinyl Estradiol 30mcg once daily for 84 days will be better in pain symptoms associated with endometriosis**.**