A Phase 2/3 interventional study of Dienogest 2 MG Oral Tablet and Yasmin in Endometriosis, sponsored by American University of Beirut Medical Center. Status unknown at 1 site in Lebanon. Open to female participants aged 20 Years to 45 Years. Per ClinicalTrials.gov, last updated 2021-04-15.
Sponsored by American University of Beirut Medical Center · Phase 2/3, Interventional, and Treatment
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.
901 studies on the registry are indexed under Endometriosis; 259 are open to participants now.
This study's planned enrollment of 100 is above the median of 64 across 525 interventional studies indexed under Endometriosis.
Browse Endometriosis studies →American University of Beirut Medical Center is the lead sponsor of 152 studies on the registry; 27 are open to participants now.
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Exclusion Criteria:
Deinogest (Visanne) 2mg/day orally for 24 weeks
Drug: Dienogest 2 MG Oral Tablet
Oral contraceptive pill (Yasmin, 0.03mg Ethinyl Estradiol and 3mg Drospirenone) orally daily for 24 weeks
Drug: Yasmin
Deinogest (Visanne) 2mg/day, orally for 24 weeks versus combined OCP (Yasmin, 0.03mg
Also known as: Visanne
0.03mg Ethinyl Estradiol and 3mg Drospirenone daily for 24 weeks
Also known as: combined oral contraceptive
Endometriosis-associated pelvic pain
be the absolute change in endometriosis -associated pelvic pain from baseline to end of treatment, assessed by the Visual Analogue Scale (VAS): with "absence of pain" corresponding to the value "0" and "unbearable pain" corresponding to the value "10"
Time frame: 6 months
Impact on Quality of life
Outcome quality of life will be assessed using Endometriosis Health Profile 30 (EHP30) with each item of this questionnaire can be answered by choosing one of the following (Never, rarely,sometimes, often and always). The endometriosis health profile is a patient-generated questionnaire in which the items were developed from interviews with women with the condition ( Obtained from Oxford University Press) .
Time frame: 6 months
incidence of side effects
Incidence of possible side effects including headache, migraine,nausea, vomiting, abdominal pain/discomfort, breast pain or tenderness, mood swings, premenstrual syndrome, decreased libido, fatigue, weight changes and menstrual irregularities
Time frame: 6 months
Patient Tolerability
Assessing tolerability to side effects via numerical scale from zero to ten ( zero not bothersome at all , ten maximum possible)
Time frame: 6 months
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American University of Beirut Medical Center