Treatment Regimen in Menstrual Cycle Regularization and Persistence in Routine Clinical Practice in Russia, Ukraine, Kazakhstan and Uzbekistan

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01711216
• Date of registration: 22/08/2012
• Prospective Registration: No
• Primary sponsor: Abbott
• Public title: Treatment Regimen in Menstrual Cycle Regularization and Persistence in Routine Clinical Practice in Russia, Ukraine, Kazakhstan and Uzbekistan
• Scientific title: A Post-Marketing, Prospective, Multicenter, Observational Program: Treatment Regimen in Menstrual Cycle Regularization and Persistence in Routine Clinical Practice in Russia, Ukraine, Kazakhstan and Uzbekistan
• Date of first enrolment: August 2012
• Target sample size: 999
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01711216
• Study type: Observational
• Phase: N/A

Countries of recruitment

Kazakhstan, Russian Federation, Ukraine, Uzbekistan

Contacts

• Name: Claire Pexman-Fieth, MD
• Affiliation: Abbott

Key inclusion & exclusion 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)



Age minimum: 18 Years
Age maximum: 40 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Irregular Menstrual Cycle

Primary Outcome(s)

Number of Patients Received Dydrogesterone Therapy Cycles (by Cycle Number) [Time Frame: up to 6 months]

Number of Patients With Regular Menstrual Cycles During Follow-up (by Number of Cycles) [Time Frame: up to 6 months]

Secondary Outcome(s)

Change of Duration of Menstrual Bleeding in Days in Group of Patients With Oligomenorrhea [Time Frame: From 1 month to 12 months]

Change of Intensity of Anxiety From Baseline to the End of Treatment [Time Frame: From 1 month to 6 months]

Patient Satisfaction With the Treatment [Time Frame: Up to 6 months]

Change of Cycle Duration From Baseline to End of Treatment in Days in Group of Patients With Polymenorrhea [Time Frame: From 1 month to 6 months]

Change of Pain Intensity During Menstruation From Baseline to End of Treatment [Time Frame: From 1 month to 6 months]

Overall Clinical Response on Treatment Assessed by Physician [Time Frame: Up to 6 months]

Proportion of Patients Reporting at Least One Regular Cycle Over the Treatment Period [Time Frame: Up to 6 months]

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 [Time Frame: Up to 12 months]

Change of Cycle Duration From Baseline to End of Treatment in Days in Group of Patients With Oligomenorrhea [Time Frame: From 1 month to 6 months]

Change of Duration of Menstrual Bleeding in Days in Group of Patients With Polymenorrhea [Time Frame: From 1 month to 12 months]

Time to Relapse [Time Frame: Up to 6 months or longer after ended treatment]

Change of Duration of Menstrual Bleeding in Group of Patients With Oligomenorrhea [Time Frame: From 1 month to 6 months]

Change of Duration of Menstrual Bleeding in Group of Patients With Polymenorrhea [Time Frame: From 1 month to 6 months]

Change of Intensity of Anxiety [Time Frame: From 1 month to 12 months]

Change of Pain Intensity During Menstruation [Time Frame: From 1 month to 12 months]

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 [Time Frame: Up to 9 months]

Secondary ID(s)

P13-688

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 30/10/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01711216