Efficacy of Dienogest Versus Oral Contraceptive Pills on Pain Associated With Endometriosis
Efficacy of Dienogest Versus Oral Contraceptive Pills on Pain Associated With Endometriosis
Endometriosis is a chronic inflammatory disease, frequently associated with dysmenorrhea,
 dyspareunia and abdomino-pelvic pain limiting quality of life. Most medical therapies aim to
 alleviate the severity of symptoms. Recent guidelines recommend the use of either OCPs or
 progestins as a first-line treatment of pain associated with endometriosis. The effectiveness
 of both OCPs and dienogest, a fourth-generation progestin, for endometriosis treatment has
 been demonstrated. The literature is rich with data comparing the use of Visanne or OCPs to
 placebo or GnRH analogs. However, there are no head to head studies comparing their efficacy
 in the management of endometriosis associated pain. The study aims to evaluate if Dienogest
 (Visanne) is not inferior in efficacy to oral contraceptive pills (Yasmin) in controlling
 pain associated with endometriosis?
Endometriosis is defined as the presence of endometrial tissue outside the uterus, which
 induces a chronic inflammatory reaction. It is an estrogen-dependent associated with pelvic
 pain and infertility. It is a relatively common chronic gynecological disease that affects
 approximately 10% of reproductive aged women. Patients with endometriosis often suffer from
 dysmenorrhea, dyspareunia, dysuria, and chronic abdominal or pelvic pain, resulting in a
 severely limited quality of life. The aim of most medical therapies is to alleviate the
 severity of symptoms. Commonly used hormonal therapies include combined oral contraceptives
 (OCP), progestogens, gonadotropin-releasing hormone (GnRH) agonists, androgens and
 antiprogestogens, all of which are considered to have similar efficacy but different
 tolerability profiles, which are often suboptimal. To date, the most widely used agent for
 the medical treatment of endometriosis is oral contraceptive (albeit off-label). In
 particular, evidence supporting the efficacy of estrogen-progestin therapy (EP) in pain
 control and reducing the risk of recurrence in women undergoing surgery for endometriosis. In
 recent years, the effectiveness of dienogest, a fourth-generation progestin, for
 endometriosis treatment has been demonstrated. Dienogest seems to be as effective as
 gonadotrophin-releasing hormone-a (GnRH-a) in terms of endometriosis-related pelvic pain
 improvement. The aim of this study is to evaluate the efficacy of Visanne versus OCP
 treatment of endometriosis associated pelvic pain in a double-blinded randomized controlled
 pilot study. It is a two armed pilot study; each group will include 50 patients. Women with
 endometriosis will be randomized to receive either DNG (n=50) or OCPs (n=50). The diagnosis
 of endometriosis will be by clinical evaluation, laparotomy, laparoscopy, or imaging analysis
 (combination of magnetic resonance imaging and ultrasonography) of endometriotic ovarian
 chocolate cysts.The first group will receive Deinogest (Visanne) 2mg/day, orally for 24
 weeks. The second group will receive monophasic combined OCP (Yasmin, Ethinyl Estradiol and
 Drospirenone) daily for 24 weeks. The treating physician and the patients will be blinded to
 the treatment option. The relief of symptoms and efficacy will be evaluated by questionnaire
 on follow up visits at 3 and 6 month of the treatment. Data collected will be analyzed and
 compared between the 2 groups. We hypothesize that there will be no difference in pain
 scores, efficacy and safety between the two treatments.
Inclusion Criteria:

 -  Patients confirmed or suspected of endometriosis on clinical evaluation (VAS score
 more than 5 and presence of subjective symptoms), surgical or imaging studies, and not
 taking any pain killer or other hormonal treatment for the moment

 -  Age 20-45

 -  Regular menstrual cycles

 -  The presence of subjective symptoms during menstruation (at least one from among lower
 abdominal pain, lumbago, defecation pain, nausea, and headache)

 -  The presence of subjective symptoms during non-menstruation (at least one from among
 lower abdominal pain, lumbago, defecation pain, dyspareunia, and pain on internal
 examination).

 Exclusion Criteria:

 -  Undiagnosed genital bleeding

 -  Use of any hormonal therapy for endometriosis within 16 weeks before enrollment

 -  A history of severe adverse drug reactions or hypersensitivity to steroid hormone

 -  Having undergone surgery therapy or surgical examination for endometriosis within a
 menstrual cycle before the start of medication

 -  Previous failure of treatment with the OCP used in the current study

 -  Contraindications to OCP or Dienogest use

 -  Smokers >35

 -  A history or complication of thrombosis/embolism

 -  Migraines with aura

 -  Depression

 -  Patients on anti-epileptics

 -  Diabetes Mellitus with vascular involvement

 -  Liver diseases

 -  Known or suspected sex hormone dependent malignancies

 -  Repeat surgery for endometriosis

 -  Patient consulting for infertility

 -  Pregnant or nursing

 -  Planning for pregnancy in near future.