Trial Outcomes & Findings for Treatment Regimen in Menstrual Cycle Regularization and Persistence in Routine Clinical Practice in Russia, Ukraine, Kazakhstan and Uzbekistan (NCT NCT01711216)

NCT ID: NCT01711216

Last Updated: 2015-12-22

Results Overview

• Recruitment status: COMPLETED
• Target enrollment: 999 participants
• Primary outcome timeframe: up to 6 months
• Results posted on: 2015-12-22

Participant Flow

A total of 1000 patients were screened. 1 Patient failed screening and 999 were enrolled into the program.

Participant milestones

Measure	Women Received Dydrogesterone for Irregular Menstrual Cycle Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
Overall Study STARTED	999
Overall Study COMPLETED	782
Overall Study NOT COMPLETED	217

Reasons for withdrawal

Measure	Women Received Dydrogesterone for Irregular Menstrual Cycle Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
Overall Study Adverse Event	4
Overall Study Pregnancy	56
Overall Study Withdrawal by Subject	6
Overall Study Lost to Follow-up	46
Overall Study variety of other minor reasons	83
Overall Study no reason specified	22

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Women Received Dydrogesterone for Irregular Menstrual Cycle n=955 Participants Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
Age, Continuous	28.3 years STANDARD_DEVIATION 5.8 • n=5 Participants
Sex: Female, Male Female	955 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment Russian Federation	382 participants n=5 Participants
Region of Enrollment Ukraine	284 participants n=5 Participants
Region of Enrollment Uzbekistan	160 participants n=5 Participants
Region of Enrollment Kazakhstan	129 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 6 months

Population: 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.

Outcome measures

Measure	Women Received Dydrogesterone for Irregular Menstrual Cycle n=860 Participants Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
Number of Patients Received Dydrogesterone Therapy Cycles (by Cycle Number) 1 therapy cycle	1 participants
Number of Patients Received Dydrogesterone Therapy Cycles (by Cycle Number) 2 therapy cycles	4 participants
Number of Patients Received Dydrogesterone Therapy Cycles (by Cycle Number) 3 therapy cycles	269 participants
Number of Patients Received Dydrogesterone Therapy Cycles (by Cycle Number) 4 therapy cycles	66 participants
Number of Patients Received Dydrogesterone Therapy Cycles (by Cycle Number) 5 therapy cycles	53 participants
Number of Patients Received Dydrogesterone Therapy Cycles (by Cycle Number) 6 therapy cycles	467 participants

PRIMARY outcome

Timeframe: up to 6 months

Population: 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.

Outcome measures

Measure	Women Received Dydrogesterone for Irregular Menstrual Cycle n=860 Participants Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
Number of Patients With Regular Menstrual Cycles During Follow-up (by Number of Cycles) 5 regular cycles	56 participants
Number of Patients With Regular Menstrual Cycles During Follow-up (by Number of Cycles) 6 regular cycles	545 participants
Number of Patients With Regular Menstrual Cycles During Follow-up (by Number of Cycles) 7 regular cycles	84 participants
Number of Patients With Regular Menstrual Cycles During Follow-up (by Number of Cycles) 0 regular cycles	6 participants
Number of Patients With Regular Menstrual Cycles During Follow-up (by Number of Cycles) 1 regular cycle	32 participants
Number of Patients With Regular Menstrual Cycles During Follow-up (by Number of Cycles) 2 regular cycles	31 participants
Number of Patients With Regular Menstrual Cycles During Follow-up (by Number of Cycles) 3 regular cycles	29 participants
Number of Patients With Regular Menstrual Cycles During Follow-up (by Number of Cycles) 4 regular cycles	26 participants
Number of Patients With Regular Menstrual Cycles During Follow-up (by Number of Cycles) 8 regular cycles	40 participants
Number of Patients With Regular Menstrual Cycles During Follow-up (by Number of Cycles) 9 regular cycles	11 participants

SECONDARY outcome

Timeframe: Up to 6 months

Population: Full Analysis Set (FAS): All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles

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

Outcome measures

Measure	Women Received Dydrogesterone for Irregular Menstrual Cycle n=955 Participants Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
Proportion of Patients Reporting at Least One Regular Cycle Over the Treatment Period	99.1 percentage of subjects

SECONDARY outcome

Timeframe: From 1 month to 6 months

Population: 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

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

Outcome measures

Measure	Women Received Dydrogesterone for Irregular Menstrual Cycle n=109 Participants Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
Change of Cycle Duration From Baseline to End of Treatment in Days in Group of Patients With Polymenorrhea	4.9 days Standard Deviation 5.9

SECONDARY outcome

Timeframe: From 1 month to 6 months

Population: 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

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

Outcome measures

Measure	Women Received Dydrogesterone for Irregular Menstrual Cycle n=711 Participants Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
Change of Cycle Duration From Baseline to End of Treatment in Days in Group of Patients With Oligomenorrhea	-15.7 days Standard Deviation 19.8

SECONDARY outcome

Timeframe: From 1 month to 6 months

Population: 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

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

Outcome measures

Measure	Women Received Dydrogesterone for Irregular Menstrual Cycle n=110 Participants Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
Change of Duration of Menstrual Bleeding in Group of Patients With Polymenorrhea	-1.7 days Standard Deviation 2.5

SECONDARY outcome

Timeframe: From 1 month to 6 months

Population: 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

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

Outcome measures

Measure	Women Received Dydrogesterone for Irregular Menstrual Cycle n=721 Participants Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
Change of Duration of Menstrual Bleeding in Group of Patients With Oligomenorrhea	-1.4 days Standard Deviation 2.0

SECONDARY outcome

Timeframe: From 1 month to 6 months

Population: 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

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

Outcome measures

Measure	Women Received Dydrogesterone for Irregular Menstrual Cycle n=916 Participants Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
Change of Pain Intensity During Menstruation From Baseline to End of Treatment	-2.8 units on a scale Standard Deviation 2.8

SECONDARY outcome

Timeframe: From 1 month to 6 months

Population: 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.

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

Outcome measures

Measure	Women Received Dydrogesterone for Irregular Menstrual Cycle n=904 Participants Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
Change of Intensity of Anxiety From Baseline to the End of Treatment	-2.7 units on a scale Standard Deviation 2.8

SECONDARY outcome

Timeframe: Up to 6 months

Population: 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.

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.

Outcome measures

Measure	Women Received Dydrogesterone for Irregular Menstrual Cycle n=919 Participants Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
Patient Satisfaction With the Treatment Very satisfied	288 participants
Patient Satisfaction With the Treatment satisfied	568 participants
Patient Satisfaction With the Treatment somewhat satisfied	55 participants
Patient Satisfaction With the Treatment dissatisfied	7 participants
Patient Satisfaction With the Treatment very dissatisfied	1 participants

SECONDARY outcome

Timeframe: Up to 6 months

Population: 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.

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.

Outcome measures

Measure	Women Received Dydrogesterone for Irregular Menstrual Cycle n=919 Participants Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
Overall Clinical Response on Treatment Assessed by Physician excellent	320 participants
Overall Clinical Response on Treatment Assessed by Physician good	499 participants
Overall Clinical Response on Treatment Assessed by Physician fair	90 participants
Overall Clinical Response on Treatment Assessed by Physician poor	10 participants

SECONDARY outcome

Timeframe: Up to 9 months

Population: 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.

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

Outcome measures

Measure	Women Received Dydrogesterone for Irregular Menstrual Cycle n=860 Participants Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
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 yes	91.7 percentage of subjects
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 no	8.3 percentage of subjects

SECONDARY outcome

Timeframe: Up to 12 months

Population: 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.

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

Outcome measures

Measure	Women Received Dydrogesterone for Irregular Menstrual Cycle n=860 Participants Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
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 yes	78.5 percentage of subjects
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 no	21.5 percentage of subjects

SECONDARY outcome

Timeframe: From 1 month to 12 months

Population: 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.

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

Outcome measures

Measure	Women Received Dydrogesterone for Irregular Menstrual Cycle n=103 Participants Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
Change of Duration of Menstrual Bleeding in Days in Group of Patients With Polymenorrhea	-0.0 days Standard Deviation 1.2

SECONDARY outcome

Timeframe: From 1 month to 12 months

Population: 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.

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

Outcome measures

Measure	Women Received Dydrogesterone for Irregular Menstrual Cycle n=651 Participants Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
Change of Duration of Menstrual Bleeding in Days in Group of Patients With Oligomenorrhea	0.1 days Standard Deviation 1.1

SECONDARY outcome

Timeframe: From 1 month to 12 months

Population: 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.

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

Outcome measures

Measure	Women Received Dydrogesterone for Irregular Menstrual Cycle n=860 Participants Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
Change of Pain Intensity During Menstruation	-0.3 units on a scale Standard Deviation 1.8

SECONDARY outcome

Timeframe: From 1 month to 12 months

Population: 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.

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

Outcome measures

Measure	Women Received Dydrogesterone for Irregular Menstrual Cycle n=860 Participants Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
Change of Intensity of Anxiety	-0.1 units on a scale Standard Deviation 1.7

SECONDARY outcome

Timeframe: Up to 6 months or longer after ended treatment

Population: 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

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.

Outcome measures

Measure	Women Received Dydrogesterone for Irregular Menstrual Cycle n=860 Participants Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
Time to Relapse	85 percentage of subjects

Adverse Events

Women Received Dydrogesterone for Irregular Menstrual Cycle

Serious events: 2 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Measure	Women Received Dydrogesterone for Irregular Menstrual Cycle n=986 participants at risk Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
Pregnancy, puerperium and perinatal conditions Abortion missed	0.10% 1/986 • Number of events 1 • 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.
Pregnancy, puerperium and perinatal conditions Ectopic pregnancy	0.10% 1/986 • Number of events 1 • 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.

Other adverse events

Measure	Women Received Dydrogesterone for Irregular Menstrual Cycle n=986 participants at risk Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
Reproductive system and breast disorders Metrorrhagia	0.41% 4/986 • Number of events 5 • 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.
Infections and infestations Bronchitis	0.10% 1/986 • Number of events 1 • 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.
Nervous system disorders Headache	0.10% 1/986 • Number of events 2 • 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.
Reproductive system and breast disorders Breast pain	0.20% 2/986 • Number of events 2 • 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.
Reproductive system and breast disorders Dysfunctional uterine bleeding	0.10% 1/986 • Number of events 1 • 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.
Reproductive system and breast disorders Dysmenorrhoea	0.20% 2/986 • Number of events 3 • 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.
Reproductive system and breast disorders Ovarian cyst	0.20% 2/986 • Number of events 2 • 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.
Reproductive system and breast disorders Uternine polyp	0.10% 1/986 • Number of events 1 • 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.

Additional Information

Senior Global Medical Director

Abbott

Phone: +49 160 749 0615

Email: Claire.Pexman-Fieth@abbott.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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
• Publication restrictions are in place

Restriction type: OTHER