N/A
N=1,000
Duphaston in Cycle Regularization: A Post-marketing, Prospective, Multicenter, Observational Study
Irregular Menstrual Cycle
Bottom Line
View on ClinicalTrials.gov: NCT01525563 ↗Enrolled (actual)
1,000
Serious AEs
0.1%
Results posted
Dec 2014
Primary outcome: Primary: Percentage of Patients Reporting a Regular Cycle — 96.7 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Abbott
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients Reporting a Regular Cycle |
96.7 | — |
| SECONDARY Change in Cycle Duration (in Days) From Baseline to End of Treatment (EOT) |
44.73; 28.59; -16.14 | — |
| SECONDARY Amount of Menstrual Bleeding From Baseline to End of Treatment |
3.08; 2.63; -0.45 | — |
| SECONDARY Evolution of Pain During Menstruation From Baseline to End of Treatment |
139; 200; 5; 0 | — |
| SECONDARY Overall Patient Satisfaction |
282; 532 | — |
| SECONDARY Evolution of Duration of Menstrual Bleeding From Baseline to End of Treatment |
4.99; 4.29 | — |
| SECONDARY Overall Clinical Response |
851; 0 | — |
Summary
In India Duphaston is approved and widely used for the treatment of progesterone deficiencies such as for management of dysmenorrhea, endometriosis, secondary amenorrhea, irregular cycles, dysfunctional uterine bleeding, pre-menstrual syndrome, threatened and habitual abortion, infertility due to luteal insufficiency, as well as part of hormone replacement therapy. One Indian study reported normalization of the cycle in 91.6% of women with menstrual problems after three cycles of therapy with dydrogesterone 10 mg given from 11th to the 25th day of the menstrual cycle. The mean cycle duration during dydrogesterone therapy in this study was noted to be 28.8 days, in contrast to 17.9 days (in the polymenorrhea group) and 50.6 days (in the oligomenorrhea group) before therapy. Furthermore, dydrogesterone also decreased the amount and duration of menstrual bleeding in this study.
However, there are limited data regarding Duphaston's role in achieving cycle regularization from post-marketing settings. Moreover, it is not well-known if the effect of Duphaston therapy persists after cessation of treatment and whether the persistent effect, if any, is related to the duration of Duphaston therapy.
Hence, in this observational study, given that (based on previous clinical studies as mentioned above) Duphaston plays a role in menstrual irregularities treatment, the goal is to tease out the possible implications of such treatment in terms of treatment length and response pattern.
Eligibility Criteria
Inclusion Criteria
- Women aged 18 years or older
- Suffering from irregular menstrual cycle for at least 3 months and for whom the physician decides to prescribe Duphaston, in accordance with locally approved package insert
- Patients willing to sign written authorization to provide data for the study
Exclusion Criteria
- Patients having known hypersensitivity to the active ingredient or excipients
- Patients having known or suspected progesterone-dependent neoplasms
- Patients having vaginal bleeding of unknown etiology
- Patients taking oral contraceptives
- Pregnant and lactating patients
- Any other condition that precludes use of Duphaston in a particular patient, in accordance with the contraindication, precautions and special warnings listed in the locally approve package insert (for example, patients with history of liver disease, porphyria or depression)
- Patients not willing to sign written authorization for data release consent form
Data sourced from ClinicalTrials.gov (NCT01525563). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.