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

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ClinicalTrials.gov Identifier: NCT01711216
Recruitment Status : Completed
First Posted : October 22, 2012
Results First Posted : October 30, 2015
Last Update Posted : December 22, 2015
Sponsor:
Information provided by (Responsible Party):
Abbott

Study Type Observational
Study Design Time Perspective: Prospective
Condition Irregular Menstrual Cycle
Enrollment 999
Recruitment Details  
Pre-assignment Details A total of 1000 patients were screened. 1 Patient failed screening and 999 were enrolled into the program.
Arm/Group Title Women Received Dydrogesterone for Irregular Menstrual Cycle
Hide Arm/Group Description Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
Period Title: Overall Study
Started 999
Completed 782
Not Completed 217
Reason Not Completed
Adverse Event             4
Pregnancy             56
Withdrawal by Subject             6
Lost to Follow-up             46
variety of other minor reasons             83
no reason specified             22
Arm/Group Title Women Received Dydrogesterone for Irregular Menstrual Cycle
Hide Arm/Group Description Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
Overall Number of Baseline Participants 955
Hide Baseline Analysis Population Description
Full Analysis Set (FAS): All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 955 participants
28.3  (5.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 955 participants
Female
955
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 955 participants
Russian Federation 382
Ukraine 284
Uzbekistan 160
Kazakhstan 129
1.Primary Outcome
Title Number of Patients Received Dydrogesterone Therapy Cycles (by Cycle Number)
Hide Description [Not Specified]
Time Frame up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Follow-up analysis set 915 patients. Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Data for 55 patients was missing. Therefore, 860 patients were analyzed.
Arm/Group Title Women Received Dydrogesterone for Irregular Menstrual Cycle
Hide Arm/Group Description:
Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
Overall Number of Participants Analyzed 860
Measure Type: Number
Unit of Measure: participants
1 therapy cycle 1
2 therapy cycles 4
3 therapy cycles 269
4 therapy cycles 66
5 therapy cycles 53
6 therapy cycles 467
2.Primary Outcome
Title Number of Patients With Regular Menstrual Cycles During Follow-up (by Number of Cycles)
Hide Description [Not Specified]
Time Frame up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Follow-up analysis set 915 patients. Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Data for 55 patients was missing. Therefore, 860 patients were analyzed.
Arm/Group Title Women Received Dydrogesterone for Irregular Menstrual Cycle
Hide Arm/Group Description:
Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
Overall Number of Participants Analyzed 860
Measure Type: Number
Unit of Measure: participants
0 regular cycles 6
1 regular cycle 32
2 regular cycles 31
3 regular cycles 29
4 regular cycles 26
5 regular cycles 56
6 regular cycles 545
7 regular cycles 84
8 regular cycles 40
9 regular cycles 11
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Women Received Dydrogesterone for Irregular Menstrual Cycle
Comments Test of association between the number of regular menstrual cycles during the follow-up period and the number of dydrogesterone therapy cycles received during the treatment period (Follow-up Analysis Set) Follow-up Analysis Set (N=915)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3181
Comments Test statistic (d.f.) 1.0157 (1) A Mantel–Haenszel chi-square test was used, exact p-value was computed using Monte Carlo estimation.
Method Mantel Haenszel
Comments [Not Specified]
3.Secondary Outcome
Title Proportion of Patients Reporting at Least One Regular Cycle Over the Treatment Period
Hide Description 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
Time Frame Up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles
Arm/Group Title Women Received Dydrogesterone for Irregular Menstrual Cycle
Hide Arm/Group Description:
Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
Overall Number of Participants Analyzed 955
Measure Type: Number
Unit of Measure: percentage of subjects
99.1
4.Secondary Outcome
Title Change of Cycle Duration From Baseline to End of Treatment in Days in Group of Patients With Polymenorrhea
Hide Description Polymenorrhea was defined as cycle duration < 21 days and the change in duration of the menstrual cycle during treatment was evaluated
Time Frame From 1 month to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles. Patients with polymenorrhoea in FAS
Arm/Group Title Women Received Dydrogesterone for Irregular Menstrual Cycle
Hide Arm/Group Description:
Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
Overall Number of Participants Analyzed 109
Mean (Standard Deviation)
Unit of Measure: days
4.9  (5.9)
5.Secondary Outcome
Title Change of Cycle Duration From Baseline to End of Treatment in Days in Group of Patients With Oligomenorrhea
Hide Description Oligomenorrhea is defined as cycle duration > 35 days and the change in duration of the menstrual cycle during treatment was evaluated
Time Frame From 1 month to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles. Patients with oligomenorrhoea in FAS
Arm/Group Title Women Received Dydrogesterone for Irregular Menstrual Cycle
Hide Arm/Group Description:
Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
Overall Number of Participants Analyzed 711
Mean (Standard Deviation)
Unit of Measure: days
-15.7  (19.8)
6.Secondary Outcome
Title Change of Duration of Menstrual Bleeding in Group of Patients With Polymenorrhea
Hide Description Polymenorrhea is defined as cycle duration < 21 days and the duration of menstrual bleeding was evaluated from baseline to end of treatment in days
Time Frame From 1 month to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles. Patients with polymenorrhoea in FAS
Arm/Group Title Women Received Dydrogesterone for Irregular Menstrual Cycle
Hide Arm/Group Description:
Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
Overall Number of Participants Analyzed 110
Mean (Standard Deviation)
Unit of Measure: days
-1.7  (2.5)
7.Secondary Outcome
Title Change of Duration of Menstrual Bleeding in Group of Patients With Oligomenorrhea
Hide Description Oligomenorrhea is defined as cycle duration > 35 days and the duration of menstrual bleeding was evaluated from baseline to end of treatment in days
Time Frame From 1 month to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles. Patients with oligomenorrhoea in FAS
Arm/Group Title Women Received Dydrogesterone for Irregular Menstrual Cycle
Hide Arm/Group Description:
Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
Overall Number of Participants Analyzed 721
Mean (Standard Deviation)
Unit of Measure: days
-1.4  (2.0)
8.Secondary Outcome
Title Change of Pain Intensity During Menstruation From Baseline to End of Treatment
Hide Description Pain intensity will be measured using 11-point Likert scale where 0 means no pain and 10 means worst pain
Time Frame From 1 month to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles. Data from 39 patients missing
Arm/Group Title Women Received Dydrogesterone for Irregular Menstrual Cycle
Hide Arm/Group Description:
Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
Overall Number of Participants Analyzed 916
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.8  (2.8)
9.Secondary Outcome
Title Change of Intensity of Anxiety From Baseline to the End of Treatment
Hide Description Intensity of anxiety will be measured using 11-point scale where 0 means no anxiety and 10 means maximum anxiety
Time Frame From 1 month to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles. Data for 51 patients missing.
Arm/Group Title Women Received Dydrogesterone for Irregular Menstrual Cycle
Hide Arm/Group Description:
Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
Overall Number of Participants Analyzed 904
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.7  (2.8)
10.Secondary Outcome
Title Patient Satisfaction With the Treatment
Hide Description 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.
Time Frame Up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): 955 patients. All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles. Data for 36 patients were missing. Therefore, 919 patients were analyzed.
Arm/Group Title Women Received Dydrogesterone for Irregular Menstrual Cycle
Hide Arm/Group Description:
Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
Overall Number of Participants Analyzed 919
Measure Type: Number
Unit of Measure: participants
Very satisfied 288
satisfied 568
somewhat satisfied 55
dissatisfied 7
very dissatisfied 1
11.Secondary Outcome
Title Overall Clinical Response on Treatment Assessed by Physician
Hide Description 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.
Time Frame Up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): 955 patients. All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles. Data for 36 patients were missing. Therefore, 919 patients were analyzed.
Arm/Group Title Women Received Dydrogesterone for Irregular Menstrual Cycle
Hide Arm/Group Description:
Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
Overall Number of Participants Analyzed 919
Measure Type: Number
Unit of Measure: participants
excellent 320
good 499
fair 90
poor 10
12.Secondary Outcome
Title 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
Hide Description 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
Time Frame Up to 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Data for 55 patients was missing.
Arm/Group Title Women Received Dydrogesterone for Irregular Menstrual Cycle
Hide Arm/Group Description:
Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
Overall Number of Participants Analyzed 860
Measure Type: Number
Unit of Measure: percentage of subjects
yes 91.7
no 8.3
13.Secondary Outcome
Title 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
Hide Description 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
Time Frame Up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Data for 55 patients was missing.
Arm/Group Title Women Received Dydrogesterone for Irregular Menstrual Cycle
Hide Arm/Group Description:
Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
Overall Number of Participants Analyzed 860
Measure Type: Number
Unit of Measure: percentage of subjects
yes 78.5
no 21.5
14.Secondary Outcome
Title Change of Duration of Menstrual Bleeding in Days in Group of Patients With Polymenorrhea
Hide Description Measured only for patients who had achieved cycle regularization at the end of treatment period. Polymenorrhea is defined as cycle duration < 21 days
Time Frame From 1 month to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Patients with polymenorrhea in subset of FAS.
Arm/Group Title Women Received Dydrogesterone for Irregular Menstrual Cycle
Hide Arm/Group Description:
Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
Overall Number of Participants Analyzed 103
Mean (Standard Deviation)
Unit of Measure: days
-0.0  (1.2)
15.Secondary Outcome
Title Change of Duration of Menstrual Bleeding in Days in Group of Patients With Oligomenorrhea
Hide Description Measured only for patients who had achieved cycle regularization at the end of treatment period. Oligomenorrhea is defined as cycle duration > 35 days
Time Frame From 1 month to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Patients with oligomenorrhea in subset of FAS.
Arm/Group Title Women Received Dydrogesterone for Irregular Menstrual Cycle
Hide Arm/Group Description:
Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
Overall Number of Participants Analyzed 651
Mean (Standard Deviation)
Unit of Measure: days
0.1  (1.1)
16.Secondary Outcome
Title Change of Pain Intensity During Menstruation
Hide Description 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
Time Frame From 1 month to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Data for 55 patients was missing.
Arm/Group Title Women Received Dydrogesterone for Irregular Menstrual Cycle
Hide Arm/Group Description:
Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
Overall Number of Participants Analyzed 860
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.3  (1.8)
17.Secondary Outcome
Title Change of Intensity of Anxiety
Hide Description 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
Time Frame From 1 month to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Data for 55 patients was missing.
Arm/Group Title Women Received Dydrogesterone for Irregular Menstrual Cycle
Hide Arm/Group Description:
Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
Overall Number of Participants Analyzed 860
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.1  (1.7)
18.Secondary Outcome
Title Time to Relapse
Hide Description 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.
Time Frame Up to 6 months or longer after ended treatment
Hide Outcome Measure Data
Hide Analysis Population Description

Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Data for 55 patients was missing.

Among the patients who achieved cycle regularization (Follow-up Analysis Set), a majority (>85%) maintained regular cycles for the whole follow-up period

Arm/Group Title Women Received Dydrogesterone for Irregular Menstrual Cycle
Hide Arm/Group Description:
Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
Overall Number of Participants Analyzed 860
Measure Type: Number
Unit of Measure: percentage of subjects
85
Time Frame Safety was monitored by recording of serious adverse events (SAEs) and pregnancies and spontaneously reported adverse events (AEs) from signed informed consent up to 30 days after the final dose of dydrogesterone.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Women Received Dydrogesterone for Irregular Menstrual Cycle
Hide Arm/Group Description Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
All-Cause Mortality
Women Received Dydrogesterone for Irregular Menstrual Cycle
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Women Received Dydrogesterone for Irregular Menstrual Cycle
Affected / at Risk (%) # Events
Total   2/986 (0.20%)    
Pregnancy, puerperium and perinatal conditions   
Abortion missed  1 [1]  1/986 (0.10%)  1
Ectopic pregnancy  1 [1]  1/986 (0.10%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (15.0)
[1]
no reasonable possibility of a relationship to the program drug.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Women Received Dydrogesterone for Irregular Menstrual Cycle
Affected / at Risk (%) # Events
Total   14/986 (1.42%)    
Infections and infestations   
Bronchitis  1  1/986 (0.10%)  1
Nervous system disorders   
Headache  1  1/986 (0.10%)  2
Reproductive system and breast disorders   
Metrorrhagia  1 [1]  4/986 (0.41%)  5
Breast pain  1  2/986 (0.20%)  2
Dysfunctional uterine bleeding  1  1/986 (0.10%)  1
Dysmenorrhoea  1  2/986 (0.20%)  3
Ovarian cyst  1  2/986 (0.20%)  2
Uternine polyp  1  1/986 (0.10%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (15.0)
[1]
The most commonly reported preferred term
Follow up period was limited to 6 months of observation. Pregnancy incidence was not the aim of research, however, spontaneous pregnancies were observed in 56 (5.6%) patients following standard dosages of dydrogesterone for irregular cycle treatment.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Investigator shall not publish/present the results without Abbott's prior written consent. In the event that applicable law permits Investigator to publish or present results without Abbott's prior written consent, Investigator shall provide Abbott with a complete copy of such publication or presentation at least 60 days prior to submission for publication or presentation and Investigator shall reasonably consider all comments which Abbott may provide regarding such publication or presentation
Results Point of Contact
Name/Title: Senior Global Medical Director
Organization: Abbott
Phone: +49 160 749 0615
Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01711216     History of Changes
Other Study ID Numbers: P13-688
First Submitted: August 22, 2012
First Posted: October 22, 2012
Results First Submitted: June 9, 2015
Results First Posted: October 30, 2015
Last Update Posted: December 22, 2015