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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01711216
Other study ID # P13-688
Secondary ID
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


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
See also
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Completed NCT02029144 - Observational Study of Dydrogesterone in Cycle Regularization N/A
Completed NCT01604603 - The Clinical and Biochemical Characteristics in Women With Different Menstrual Pattern N/A
Completed NCT01525563 - Duphaston in Cycle Regularization: A Post-marketing, Prospective, Multicenter, Observational Study N/A