EndometriosisPhase 2/3NCT04256200
Efficacy of Dienogest Versus Oral Contraceptive Pills on Pain Associated With Endometriosis
A Phase 2/3 study testing Dienogest 2 MG Oral Tablet and Yasmin in people with Endometriosis, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Dienogest 2 MG Oral Tablet and Yasmin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteLebanon
- Study dates
- 7 Feb 2017to Dec 2021
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 18Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Lebanon1 site, 1 recruiting
- Recruiting
American University of Beirut
Beirut
Antoine Abu Musa, MD, +9611350000 ext. 4840, aa06@aub.edu.lb
About this study
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?
Read the detailed 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.
- Conditions
- Endometriosis
- Being tested
- Dienogest 2 MG Oral Tablet, Yasmin
- Keywords
- endometriosis, oral contraceptive pills, progestin
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dienogest 2 MG Oral TabletDrug
Also called Visanne
Deinogest (Visanne) 2mg/day, orally for 24 weeks versus combined OCP (Yasmin, 0.03mg
YasminDrug
Also called combined oral contraceptive
0.03mg Ethinyl Estradiol and 3mg Drospirenone daily for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Dienogest | Active comparator | Deinogest (Visanne) 2mg/day orally for 24 weeks Receives: Drug: Dienogest 2 MG Oral Tablet |
| Oral Contraceptive Pills | Active comparator | Oral contraceptive pill (Yasmin, 0.03mg Ethinyl Estradiol and 3mg Drospirenone) orally daily for 24 weeks Receives: Drug: Yasmin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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"
Measured: 6 months
Secondary outcomes (3)
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) .
Measured: 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
Measured: 6 months
Patient Tolerability
Assessing tolerability to side effects via numerical scale from zero to ten ( zero not bothersome at all , ten maximum possible)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start7 Feb 2017
- Primary completionNov 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antoine Abou Moussa, American University of Beirut Medical Center
- Investigators
- Antoine Abu Musa, MD, Principal investigator, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04256200
- Sponsor's protocol ID
- OGY.AA.07
- Status last verified
- Apr 2021
- First submitted
- 15 Jan 2020
- Last updated
- 15 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
El Taha L, Abu Musa A, Khalifeh D, Khalil A, Abbasi S, Nassif J. Efficacy of dienogest vs combined oral contraceptive on pain associated with endometriosis: Randomized clinical trial. Eur J Obstet Gynecol Reprod Biol. 2021 Dec;267:205-212. doi: 10.1016/j.ejogrb.2021.10.029. Epub 2021 Oct 30.
PubMed 34826668
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Dienogest Versus Oral Contraceptive Pills on Pain Associated With Endometriosis
- ClinicalTrials.gov ID
- NCT04256200
- Acronym / sponsor ID
- OGY.AA.07
- Conditions
- Endometriosis
- Keywords
- endometriosis, oral contraceptive pills, progestin
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- 7 Feb 2017 (actual)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dienogest | Active comparator | Drug: Dienogest 2 MG Oral TabletDeinogest (Visanne) 2mg/day orally for 24 weeks |
| Oral Contraceptive Pills | Active comparator | Drug: YasminOral contraceptive pill (Yasmin, 0.03mg Ethinyl Estradiol and 3mg Drospirenone) orally daily for 24 weeks |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dienogest 2 MG Oral TabletAlso: VisanneDeinogest (Visanne) 2mg/day, orally for 24 weeks versus combined OCP (Yasmin, 0.03mg | Drug | Dienogest |
| YasminAlso: combined oral contraceptive0.03mg Ethinyl Estradiol and 3mg Drospirenone daily for 24 weeks | Drug | Oral Contraceptive Pills |
Primary outcome
Endometriosis-associated pelvic pain
Time frame: 6 months
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"
3 secondary outcomes
Impact on Quality of life
Time frame: 6 months
incidence of side effects
Time frame: 6 months
Patient Tolerability
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2021.
- Derived from this study: PubMed 34826668El Taha L, Abu Musa A, Khalifeh D, Khalil A, Abbasi S, Nassif J. Efficacy of dienogest vs combined oral contraceptive on pain associated with endometriosis: Randomized clinical trial. Eur J Obstet Gynecol Reprod Biol. 2021 Dec;267:205-212. doi: 10.1016/j.ejogrb.2021.10.029. Epub 2021 Oct 30.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoine Abu Musa, MD principal investigator
American University of Beirut Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dienogest 2 MG Oral Tablet and Yasmin in people with Endometriosis, run by American University of Beirut Medical Center at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antoine Abu Musa, M.D. (+9611350000 ext. 5840, aa06@aub.edu.lb), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endometriosis-associated pelvic pain (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04256200, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2021.