The Effect of Dienogest vs. Norethindrone Acetate Treatment in Endometriosis
DINE
1 other identifier
interventional
70
1 country
1
Brief Summary
This randomized controlled study aims to investigate the efficiency of medical treatment modalities in endometriosis patients. The study protocol involves two arms. (Dienogest Group and Noretindrone Acetate Group). The patients diagnosed with endometriosis are randomized depending on their protocol ids. The Dienogest group is prescribed 5 mg dienogest per day and neta group is prescribed 5 mg neta per day. The pain scores will be analyzed six months and twelve months after treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2021
CompletedFirst Submitted
Initial submission to the registry
July 7, 2022
CompletedFirst Posted
Study publicly available on registry
July 27, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2023
CompletedJuly 21, 2023
July 1, 2023
2.2 years
July 7, 2022
July 20, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Chronic Pelvic Pain
Numeric Score before and after treatment
Change from Baseline Score at 6 months
Chronic Pelvic Pain
Numeric Score before and after treatment
Change from Baseline Score at 12 months
Secondary Outcomes (2)
Side Effect Rate
Rate of Side Effect from baseline at 6 months
Side Effect Rate
Rate of Side Effect from baseline at 12 months
Study Arms (2)
Dienogest
ACTIVE COMPARATORPatients with endometriosis are prescribed dienogest for treatment.
Norethindrone Acetate
ACTIVE COMPARATORPatients with endometriosis are prescribed Norethindrone Acetate for treatment.
Interventions
The effect of dienogest on endometriosis pain symptoms.
The effect of Norethindrone Acetateon endometriosis pain symptoms.
Eligibility Criteria
You may qualify if:
- years aged women diagnosed with endometriosis
You may not qualify if:
- malignancy
- need for surgery
- pregnancy desire
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Uludag University
Bursa, Nilufer, Turkey (Türkiye)
Related Publications (1)
Gurbuz TB, Aslan K, Kasapoglu I, Muzii L, Uncu G. Norethindrone acetate versus dienogest for pain relief in endometriosis related pain: A randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2025 Jun;310:113940. doi: 10.1016/j.ejogrb.2025.113940. Epub 2025 Mar 29.
PMID: 40233572DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kiper Aslan, Assoc. Prof.
Uludag University
- PRINCIPAL INVESTIGATOR
Isil Kasapoglu, Assoc. Prof.
Uludag University
- STUDY CHAIR
Gurkan Uncu, Prof.
Uludag University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 7, 2022
First Posted
July 27, 2022
Study Start
April 1, 2021
Primary Completion
May 30, 2023
Study Completion
June 30, 2023
Last Updated
July 21, 2023
Record last verified: 2023-07