N/A
N=999
Treatment Regimen in Menstrual Cycle Regularization and Persistence in Routine Clinical Practice in Russia, Ukraine, Kazakhstan and Uzbekistan
Irregular Menstrual Cycle
Bottom Line
View on ClinicalTrials.gov: NCT01711216 ↗Enrolled (actual)
999
Serious AEs
0.2%
Results posted
Oct 2015
Primary outcome: Primary: Number of Patients Received Dydrogesterone Therapy Cycles (by Cycle Number) — 1; 4; 269; 66 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Abbott
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Received Dydrogesterone Therapy Cycles (by Cycle Number) |
1; 4; 269; 66; 53; 467 | — |
| PRIMARY Number of Patients With Regular Menstrual Cycles During Follow-up (by Number of Cycles) |
6; 32; 31; 29; 26; 56 | 0.3181 |
| SECONDARY Proportion of Patients Reporting at Least One Regular Cycle Over the Treatment Period |
99.1 | — |
| SECONDARY Change of Cycle Duration From Baseline to End of Treatment in Days in Group of Patients With Polymenorrhea |
4.9 | — |
| SECONDARY Change of Cycle Duration From Baseline to End of Treatment in Days in Group of Patients With Oligomenorrhea |
-15.7 | — |
| SECONDARY Change of Duration of Menstrual Bleeding in Group of Patients With Polymenorrhea |
-1.7 | — |
| SECONDARY Change of Duration of Menstrual Bleeding in Group of Patients With Oligomenorrhea |
-1.4 | — |
| SECONDARY Change of Pain Intensity During Menstruation From Baseline to End of Treatment |
-2.8 | — |
| SECONDARY Change of Intensity of Anxiety From Baseline to the End of Treatment |
-2.7 | — |
| SECONDARY Patient Satisfaction With the Treatment |
288; 568; 55; 7; 1 | — |
| SECONDARY Overall Clinical Response on Treatment Assessed by Physician |
320; 499; 90; 10 | — |
| SECONDARY Proportion of Patients With 3 Consecutive Regular Cycles Out of Total Number of Patients Who Had Achieved Cycle Regularization at the End of Treatment Period |
91.7; 8.3 | — |
| SECONDARY Proportion of Patients With 6 Consecutive Regular Cycles Out of Total Number of Patients Who Had Achieved Cycle Regularization at the End of Treatment Period |
78.5; 21.5 | — |
| SECONDARY Change of Duration of Menstrual Bleeding in Days in Group of Patients With Polymenorrhea |
-0.0 | — |
| SECONDARY Change of Duration of Menstrual Bleeding in Days in Group of Patients With Oligomenorrhea |
0.1 | — |
| SECONDARY Change of Pain Intensity During Menstruation |
-0.3 | — |
| SECONDARY Change of Intensity of Anxiety |
-0.1 | — |
| SECONDARY Time to Relapse |
85 | — |
Summary
Dydrogesterone is approved in more than 100 countries including Russia, Ukraine, Kazakhstan and Uzbekistan 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 miscarriage, infertility due to luteal insufficiency, as well as part of hormone replacement therapy. There are limited data regarding dydrogesterone's role in achieving cycle regularization from post-marketing settings. There is need to assess the persistence of dydrogesterone therapy in a post-marketing setting after cessation of treatment and whether the persistence, if any, is related to the duration of dydrogesterone therapy. Hence, in this observational program, the goal is to observe the possible implications of such treatment in terms of treatment length and response pattern.
Eligibility Criteria
Inclusion Criteria
- Women aged 18-40 years
- Irregular menstrual cycle due to progesterone deficiency for at least 3 months
- Dydrogesterone prescribed in accordance with locally approved package insert
- Signed written authorization to provide data for the program
Exclusion Criteria
- Known hypersensitivity to the active ingredient or excipients
- Known or suspected progesterone-dependent neoplasms
- Vaginal bleeding of unknown etiology
- Administration of oral contraceptives
- Any other condition that precludes use of dydrogesterone in a particular patient, in accordance with the contraindication, precautions and special warnings listed in the locally approve package insert (for example, patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption)
Data sourced from ClinicalTrials.gov (NCT01711216). 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.