Efficacy of Dienogest Versus Oral Contraceptive Pills on Pain Associated With Endometriosis

  • STATUS
    Recruiting
  • End date
    Dec 27, 2021
  • participants needed
    100
  • sponsor
    American University of Beirut Medical Center
Updated on 27 April 2021
analgesia
regular menstrual cycles
progestin
abdominal pain
dysmenorrhea
pelvic pain
endometriosis
dyspareunia
dienogest
estradiol
inflammatory disease
dyschezia
dienogest 2 mg

Summary

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?

Description

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.

Details
Condition Endometriosis, Female Genital Diseases, Gynecological Infections
Treatment Yasmin, Dienogest 2 MG Oral Tablet
Clinical Study IdentifierNCT04256200
SponsorAmerican University of Beirut Medical Center
Last Modified on27 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 20 yrs and 45 yrs?
Are you female?
Do you have any of these conditions: Endometriosis or Gynecological Infections or Female Genital Diseases?
Do you have any of these conditions: Gynecological Infections or Endometriosis or Female Genital Diseases?
Do you have any of these conditions: Endometriosis or Female Genital Diseases or Gynecological Infections?
Do you have any of these conditions: Endometriosis or Female Genital Diseases or Gynecological Infections?
Do you have any of these conditions: Endometriosis or Gynecological Infections or Female Genital Diseases?
Do you have any of these conditions: Endometriosis or Female Genital Diseases or Gynecological Infections?
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
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