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

A randomized, open-label, parallel-group controlled trial investigating the efficacy and safety of long-term low-dose Dienogest in patients with dysmenorrhea due to endometriosis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs041210016

Enrollment

Registered

2021-05-11

Start date

2021-08-13

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

dysmenorrhea due to endometriosis endometriosis dysmenorrhea

Interventions

0.5 mg group: Dienogest 0.5 mg twice daily, 1 tablet at a time for 48 weeks. 1 mg group: Dienogest 1 mg twice daily, 1 tablet at a time for 48 weeks.

Eligibility

Sex/Gender

Female

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Changes in VAS 48 weeks after baseline administration	—

Secondary

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

Measure

Time frame

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

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Contacts

Public ContactKyoko Kikuno

Gifu University Hospital

kikuno.kyoko.f0@f.gifu-u.ac.jp+81-58-230-6000

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026