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The efficacy and safety of didrogesterone in the treatment of patients with dysmenorrhea: an open, randomized, controlled clinical study

The efficacy and safety of didrogesterone in the treatment of patients with dysmenorrhea: an open, randomized, controlled clinical study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100043308
Enrollment
Unknown
Registered
2021-02-09
Start date
2021-02-02
Completion date
Unknown
Last updated
2021-06-07

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

Conditions

Dysmenorrhea

Interventions

Didrogesterone treatment group:10 mg of dydrogesterone was given orally twice a day from the 5th day to the 25th day of the menstrual cycle for 3 menstrual cycles.
Cassia zhiporing capsule treatment group:0.93 g of Guizhiporing Capsules was given orally ter in die while menstrual bleeding stops continuously to the 2th day of the next menstrual cycle for 3 menst

Sponsors

Guangdong Provincial Maternal and Child Health Hospital affiliated to Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Dysmenorrhea occurred on the 1st-5th day of menstruation or the 1st day before menstruation and met the following conditions: 1. Subjects aged 18-45 years; 2. Subjects who did not use hormonal and endocrine drugs within 3 months before the treatment had no history of using sedatives or analgesics in the first month; 3. The subjects who are willing and able to comply with the study protocol have the ability to clearly judge the pain intensity; 4. All patients with dysmenorrhea secondary to endometriosis have no operation indication or refuse operation treatment, and strongly demand drug treatment for pain.

Exclusion criteria

Exclusion criteria: 1. Patients with severe liver and kidney diseases; 2. Patients allergic to any component of the study drug; 3. Patients with severe cardiovascular disease; 4. Patients with porphyria; 5. Patients with hormone dependent tumor; 6. Patients with meningioma.

Design outcomes

Primary

MeasureTime frame
Visual Analogue Scale;

Secondary

MeasureTime frame
the Short Form Health Survey (SF-36);Cox Menstrual Symptom Scale;Simplified McGill Pain Questionnaire;menstruations;

Countries

China

Contacts

Public ContactLi Li

Guangdong maternal and Child Health Hospital

13631446859@163.com+86 13631446859

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026