The efficacy and safety of long-term low-dose Dienogest in patients with dysmenorrhea due to endometriosis.

Not Applicable

Recruiting

• Conditions: dysmenorrhea due to endometriosis; endometriosis dysmenorrhea

• Registration Number: JPRN-jRCTs041210016
• Lead Sponsor: Kikuno Kyoko

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-11
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 88

Inclusion Criteria

1.Patients who have been diagnosed with endometriosis (ovarian endometriotic cyst) and do not plan to undergo surgery
2. Patients with dysmenorrhea
3. Patients who plan to continue using Dienogest for more than 48 weeks.
4.Patients over 20years old to premenopausal at the time of consent
5.Patients who have written consent to participate in this study

Exclusion Criteria

1.Patients who have been diagnosed with endometriosis (ovarian endometriotic cyst) and do not plan to undergo surgery
2. Patients with dysmenorrhea
3. Patients who plan to continue using Dienogest for more than 48 weeks.
4.Patients over 20years old to premenopausal at the time of consent
5.Patients who have written consent to participate in this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in VAS 48 weeks after baseline administration

Secondary Outcome Measures

Name	Time	Method
1.Incidence of low estrogen symptoms during reserch treatment(quantified using menopausal score)<br>2.Changes in dysmenorrhea score 48 weeks after dosing from baseline<br>3.Changes in menopausal score 48 weeks after dosing from baseline<br>4.Rate of reduction in ovarian endometriotic cyst size 48 weeks after baseline administration<br>5.Change in bone mineral density 48 weeks after administration from baseline<br>6.Primary endopoints and secondary endopoints above at 12,24,and 36 weeks.