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

Irregular Menstrual Cycle Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01711216
• Other study ID #: P13-688
• Status: Completed
• Phase: N/A
• First received: August 22, 2012
• Last updated: November 23, 2015
• Start date: August 2012
• Est. completion date: August 2014

Study information

• Verified date: November 2015
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian FederationUkraine: Ministry of HealthKazakhstan: Ministry of Public HealthUzbekistan: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 999
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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)

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Irregular Menstrual Cycle

Locations

Country	Name	City	State
Kazakhstan	Site reference ID/Investiagor# 82286	Aktobe
Kazakhstan	Site reference ID/Investiagor# 82287	Aktobe
Kazakhstan	Site reference ID/Investigator# 101795	Aktobe
Kazakhstan	Site reference ID/Investigator# 101798	Aktobe
Kazakhstan	Site reference ID/Investigator# 101799	Aktobe
Kazakhstan	Site reference ID/Investigator# 82279	Aktobe
Kazakhstan	Site reference ID/Investiagor# 82281	Almaty
Kazakhstan	Site reference ID/Investigator# 82293	Almaty
Kazakhstan	Site reference ID/Investigator# 101796	Astana
Kazakhstan	Site reference ID/Investigator# 101797	Astana
Kazakhstan	Site reference ID/Investigator# 82277	Astana
Kazakhstan	Site reference ID/Investigator# 82299	Astana
Kazakhstan	Site reference ID/Investigator# 82300	Astana
Kazakhstan	Site reference ID/Investigator# 82301	Astana
Kazakhstan	Site reference ID/Investiagor# 82282	Shymkent
Kazakhstan	Site reference ID/Investigator# 82275	Shymkent
Kazakhstan	Site reference ID/Investigator# 82288	Shymkent
Russian Federation	Site reference ID/Investigator# 82035	Ekaterinburg
Russian Federation	Site reference ID/Investigaotr# 76702	Irkutsk
Russian Federation	Site reference ID/Investigator# 77753	Kazan
Russian Federation	Site reference ID/Investigaotr# 76704	Kemerovo
Russian Federation	Site reference ID/Investigator# 76701	Krasnodar
Russian Federation	Site reference ID/Investigaot# 88535	Moscow
Russian Federation	Site reference ID/Investigaot# 88537	Moscow
Russian Federation	Site reference ID/Investigaotr# 76708	Moscow
Russian Federation	Site reference ID/Investigator# 76700	Moscow
Russian Federation	Site reference ID/Investigator# 87013	Moscow
Russian Federation	Site reference ID/Investigaot# 88514	Nizhniy Novgorod
Russian Federation	Site reference ID/Investigator# 83633	Novosibirsk
Russian Federation	Site reference ID/Investigaot# 88536	St. Petersburg
Russian Federation	Site reference ID/Investigaotr# 76709	St. Petersburg
Russian Federation	Site reference ID/Investigator# 77754	St. Petersburg
Russian Federation	Site reference ID/Investigaotr# 76705	Tomsk
Russian Federation	Site reference ID/Investigator# 77755	Tumen
Russian Federation	Site reference ID/Investigator# 82036	Volgograd
Russian Federation	Site reference ID/Investigaot# 88513	Voronezh
Ukraine	Site reference ID/Investigaot# 75815	Dnipropetrovsk
Ukraine	Site Reference ID/Investigator# 75816	Ivano-Frankivsk
Ukraine	Site reference #/Investigator ID 77816	Kharkiv
Ukraine	Site reference ID/Investigaot# 75817	Kharkiv
Ukraine	Site reference ID/Investigaot# 75813	Kiev
Ukraine	Site Reference ID/Investigator# 75814	Kiev
Ukraine	Site reference ID/Investigaot# 88056	Lviv
Ukraine	Site reference ID/Investigaot# 75819	Mykolaiv
Ukraine	Site reference ID/Investigaot# 77817	Odesa
Ukraine	Site reference ID/Investigaot# 80193	Odesa
Ukraine	Site reference ID/Investigator # 77813	Ternopil
Ukraine	Site reference ID/Investigaot# 75818	Vinnytsia
Ukraine	Site Reference ID/Investigator# 75822	Zaporizhzhia
Uzbekistan	Site reference ID/Investigaot# 91973	Andijan
Uzbekistan	Site reference ID/Investigaot# 91974	Andijan
Uzbekistan	Site reference ID/Investigaot# 91987	Bukhara
Uzbekistan	Site reference ID/Investigaot# 91975	Fergana
Uzbekistan	Site reference ID/Investigaot# 91986	Samarkand
Uzbekistan	Site reference ID/Investigaot# 100616	Tashkent
Uzbekistan	Site reference ID/Investigaot# 91976	Tashkent
Uzbekistan	Site reference ID/Investigaot# 91977	Tashkent
Uzbekistan	Site reference ID/Investigaot# 91981	Tashkent
Uzbekistan	Site reference ID/Investigaot# 91982	Tashkent
Uzbekistan	Site reference ID/Investigaot# 91983	Tashkent
Uzbekistan	Site reference ID/Investigaot# 91984	Tashkent
Uzbekistan	Site reference ID/Investigaot# 91988	Tashkent
Uzbekistan	Site reference ID/Investigaot# 92473	Tashkent
Uzbekistan	Site reference ID/Investigaot# 92474	Tashkent
Uzbekistan	Site reference ID/Investigaot# 91980	Urgench
Uzbekistan	Site reference ID/Investigaot# 91985	Urgench

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Countries where clinical trial is conducted

Kazakhstan,  Russian Federation,  Ukraine,  Uzbekistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients Received Dydrogesterone Therapy Cycles (by Cycle Number)		up to 6 months	No
Primary	Number of Patients With Regular Menstrual Cycles During Follow-up (by Number of Cycles)		up to 6 months	No
Secondary	Proportion of Patients Reporting at Least One Regular Cycle Over the Treatment Period	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	Up to 6 months	No
Secondary	Change of Cycle Duration From Baseline to End of Treatment in Days in Group of Patients With Polymenorrhea	Polymenorrhea was defined as cycle duration < 21 days and the change in duration of the menstrual cycle during treatment was evaluated	From 1 month to 6 months	No
Secondary	Change of Cycle Duration From Baseline to End of Treatment in Days in Group of Patients With Oligomenorrhea	Oligomenorrhea is defined as cycle duration > 35 days and the change in duration of the menstrual cycle during treatment was evaluated	From 1 month to 6 months	No
Secondary	Change of Duration of Menstrual Bleeding in Group of Patients With Polymenorrhea	Polymenorrhea is defined as cycle duration < 21 days and the duration of menstrual bleeding was evaluated from baseline to end of treatment in days	From 1 month to 6 months	No
Secondary	Change of Duration of Menstrual Bleeding in Group of Patients With Oligomenorrhea	Oligomenorrhea is defined as cycle duration > 35 days and the duration of menstrual bleeding was evaluated from baseline to end of treatment in days	From 1 month to 6 months	No
Secondary	Change of Pain Intensity During Menstruation From Baseline to End of Treatment	Pain intensity will be measured using 11-point Likert scale where 0 means no pain and 10 means worst pain	From 1 month to 6 months	No
Secondary	Change of Intensity of Anxiety From Baseline to the End of Treatment	Intensity of anxiety will be measured using 11-point scale where 0 means no anxiety and 10 means maximum anxiety	From 1 month to 6 months	No
Secondary	Patient Satisfaction With the Treatment	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.	Up to 6 months	No
Secondary	Overall Clinical Response on Treatment Assessed by Physician	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.	Up to 6 months	No
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	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	Up to 9 months	No
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	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	Up to 12 months	No
Secondary	Change of Duration of Menstrual Bleeding in Days in Group of Patients With Polymenorrhea	Measured only for patients who had achieved cycle regularization at the end of treatment period. Polymenorrhea is defined as cycle duration < 21 days	From 1 month to 12 months	No
Secondary	Change of Duration of Menstrual Bleeding in Days in Group of Patients With Oligomenorrhea	Measured only for patients who had achieved cycle regularization at the end of treatment period. Oligomenorrhea is defined as cycle duration > 35 days	From 1 month to 12 months	No
Secondary	Change of Pain Intensity During Menstruation	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	From 1 month to 12 months	No
Secondary	Change of Intensity of Anxiety	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	From 1 month to 12 months	No
Secondary	Time to Relapse	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.	Up to 6 months or longer after ended treatment	No