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Clinical trial of the efficacy and safety of dydrogesterone in dysmenorrhoea patients.

Clinical trial of the efficacy and safety of dydrogesterone in dysmenorrhoea patients. - Clinical trial of dydrogesterone in dysmenorrhoea patients.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000022779
Enrollment
45
Registered
2016-07-01
Start date
2016-07-01
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

Dysmenorrhoea

Interventions

The oral administration twice a day for 21 days. This cycle is repeated four times.

Sponsors

Tottori University Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Patients with diagnosis of primary or secondary dysmenorrhea. 2. The menstrual cycle is 28 plus or minus 3 days. 3. The total number of the dysmenorrhea score is three points or more at the time of registering.

Exclusion criteria

Exclusion criteria: 1. Patients with medical history of serious liver failure or liver disease. 2. Patients with medical history of heart disease or kidney disease 3. Patients with porphyria. 4. Patients with medical history of peptic ulceration. 5. Patients with severe abnormal clinical examination. 6. Patients with asthma bronchial or asthma aspirin-sensitive. 7. Patients with colitis ulcerative or Crohn's disease. 8. Treatment with luteal hormone or follicular hormone-based hormone agents, low dose pill, middle dose pill, GnRH agonist, testosterone derivative, follicular hormone antagonist, aromatase inhibitor, Chinese herbal medicine for dysmenorrhea or within 2 months of initiation of administration 9. Treatment with transvaginal alcohol fixative, surgical therapy by laparotomy or laparoscope within 2 months of initiation of administration.

Design outcomes

Primary

MeasureTime frame
Valuation of total dysmenorrhea score.

Secondary

MeasureTime frame
VAS of pain by dysmenorrhea, dysmenorrhea score, objective, adverse experience

Countries

Japan

Contacts

Public ContactFuminori Taniguchi

Tottori University Hospital Division of Reproductive-Perinatal Medicine and Gynecologic Oncology

tani4327@grape.med.tottori-u.ac.jp0859-38-6647

Outcome results

None listed

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