Clinical trial

The Effect of Dienogest vs. Norethindrone Acetate Treatment in Endometriosis

Name

2022-8/23

Description

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 arms

Trial start

2021-04-01

Estimated PCD

2023-05-30

Trial end

2023-06-30

Status

Completed

Treatment

Dienogest Pill

The effect of dienogest on endometriosis pain symptoms.

Arms:

Dienogest

Other names:

Visanne Group

Norethindrone Acetate

The effect of Norethindrone Acetateon endometriosis pain symptoms.

Arms:

Norethindrone Acetate

Other names:

Primolut-N Group

Size

Primary endpoint

Chronic Pelvic Pain

Change from Baseline Score at 6 months

Chronic Pelvic Pain

Change from Baseline Score at 12 months

Eligibility criteria

Inclusion Criteria: * 18 - 40 years aged women diagnosed with endometriosis Exclusion Criteria: * malignancy * need for surgery * pregnancy desire

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 70, 'type': 'ACTUAL'}}

Updated at

2023-07-21

1 organization

2 products

1 indication

Organization

Product

Indication

Product