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Completed

NCT Number: NCT01711216

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

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.

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Key information

Conditions

Irregular Menstrual Cycle Menstruation Disturbances Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Site reference ID/Investiagor# 82286, Aktobe, Kazakhstan

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About this study

The program is designed as a prospective, multicentre, observational, non-interventional, non-randomized, non-controlled, single arm, post-marketing program. Being an observational program, the assignment of patients to dydrogesterone therapy will not be decided with an intention to include patients in the program, but will be guided as per standard clinical practice of the treating physician. Hence the prescribing of dydrogesterone will be clearly separate from the decision to include patients in this program. All dydrogesterone prescriptions will be made in accordance with locally approved package insert for dydrogesterone.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Number of Patients Received Dydrogesterone Therapy Cycles (by Cycle Number)

    Time frame: up to 6 months

  2. Number of Patients With Regular Menstrual Cycles During Follow-up (by Number of Cycles)

    Time frame: up to 6 months

Secondary outcomes

  1. Proportion of Patients Reporting at Least One Regular Cycle Over the Treatment Period

    Time frame: Up to 6 months

    Regular cycle is defined as cycle duration between 21 to 35 days, inclusive. Treatment period in this observational program can be from 1 cycle to 6 consecutive cycles. This program does not include patients who required dydrogesterone therapy, according to physician's decision, more than 6 consecutive cycles

  2. 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

    Polymenorrhea was defined as cycle duration < 21 days and the change in duration of the menstrual cycle during treatment was evaluated

  3. 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

    Oligomenorrhea is defined as cycle duration > 35 days and the change in duration of the menstrual cycle during treatment was evaluated

  4. Change of Duration of Menstrual Bleeding in Group of Patients With Polymenorrhea

    Time frame: From 1 month to 6 months

    Polymenorrhea is defined as cycle duration < 21 days and the duration of menstrual bleeding was evaluated from baseline to end of treatment in days

  5. Change of Duration of Menstrual Bleeding in Group of Patients With Oligomenorrhea

    Time frame: From 1 month to 6 months

    Oligomenorrhea is defined as cycle duration > 35 days and the duration of menstrual bleeding was evaluated from baseline to end of treatment in days

  6. Change of Pain Intensity During Menstruation From Baseline to End of Treatment

    Time frame: From 1 month to 6 months

    Pain intensity will be measured using 11-point Likert scale where 0 means no pain and 10 means worst pain

  7. Change of Intensity of Anxiety From Baseline to the End of Treatment

    Time frame: From 1 month to 6 months

    Intensity of anxiety will be measured using 11-point scale where 0 means no anxiety and 10 means maximum anxiety

  8. Patient Satisfaction With the Treatment

    Time frame: Up to 6 months

    Patient satisfaction will be determined based on a 5-point Clinical Global Impression of Severity scale, where 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat satisfied, 4 = satisfied, 5 = very satisfied.

  9. Overall Clinical Response on Treatment Assessed by Physician

    Time frame: Up to 6 months

    Overall clinical response assessed by physician will be determined based on a four-point-scale, where 4 = excellent, 3 = good, 2 = fair, and 1 = poor response.

  10. 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

    Measured only for patients who had achieved cycle regularization at the end of treatment period. Regular cycle is defined as cycle duration 21-35 days, inclusive

  11. 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

    Measured only for patients who had achieved cycle regularization at the end of treatment period. Regular cycle is defined as cycle duration 21-35 days, inclusive

  12. Change of Duration of Menstrual Bleeding in Days in Group of Patients With Polymenorrhea

    Time frame: From 1 month to 12 months

    Measured only for patients who had achieved cycle regularization at the end of treatment period. Polymenorrhea is defined as cycle duration < 21 days

  13. Change of Duration of Menstrual Bleeding in Days in Group of Patients With Oligomenorrhea

    Time frame: From 1 month to 12 months

    Measured only for patients who had achieved cycle regularization at the end of treatment period. Oligomenorrhea is defined as cycle duration > 35 days

  14. Change of Pain Intensity During Menstruation

    Time frame: From 1 month to 12 months

    Measured only for patients who had achieved cycle regularization at the end of treatment period. Pain intensity will be measured using 11-point Likert scale where 0 means no pain and 10 means worst pain

  15. Change of Intensity of Anxiety

    Time frame: From 1 month to 12 months

    Will be measured only for patients who had achieved cycle regularization at the end of treatment period. Intensity of anxiety will be measured using 11-point scale where 0 means no anxiety and 10 means maximum anxiety

  16. Time to Relapse

    Time frame: Up to 6 months or longer after ended treatment

    The intention was to measure time to relapse, but since a regular cycle was maintained longer than the period of follow up observation, no resulting variable counted in time was received. Instead, what was measured was the percentage of participants who maintained a regular cycle. Measured only for patients who had achieved cycle regularization at the end of treatment period.

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Oct 22, 2012
Registry last updated
Dec 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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