Uterine Fibroids
Conditions
Keywords
Uterine fibroids
Brief summary
ZPU-003 EXT is a 2-year extension study of ZPU-003 (NCT00882258) to determine the continued safety and efficacy of Proellex in women who have previously completed the double-blind portion of the study.
Detailed description
ZPU-003 EXT is a 2-year extension study of ZPU-003 (NCT00882258). The purpose of the study is to determine the continued safety and efficacy of Proellex in women who have previously completed the double-blind portion of the study. The desired primary efficacy outcome will be a changes in vaginal bleeding from baseline to 14 months and 17 months on study drug. The total duration of the study is up to 24 months including transition times, off drug intervals, and follow-up visits). It is expected that over a 16 week on drug interval menses will subside and return after a 4-8 week off drug interval (ODI).
Interventions
DRUGProellex®
25 mg daily (two 12.5 mg capsules)
Sponsors
Repros Therapeutics Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Completed the ZPU 003 study and met the inclusion/
Exclusion criteria
of that study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Change in Menorrhagia From the Baseline of ZPU-003 to the End of Each Off Drug Interval(ODI) Within the ZPU-003 Extension Study and the Baseline of ZPU-003 to the End of ZPU-003 Ext. | Baseline to 17 months | An ODI is defined as a time period of less than 3 months during which a return to menses occurs. All statistical endpoints will use the baseline of ZPU-003 Ext for 14-month data and baseline of ZPU-003 for 17-month data. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline of ZPU-003 Ext to 14 Months and 17 Months in Subject's Menstrual Pictogram Scores (mL) (Subjects Evaluable for Menorrhagia Only) | Baseline, 14 months, 17 months | Patient assessed all menstrual products used for bleeding during the month-long time period between study visits. For the total menstrual pictogram score, a lower score indicated less menstrual bleeding, a higher score indicated more menstrual bleeding. Over the course of a menstrual cycle, each pad was scored on an ordinal scale from 1 to 5, each tampon scored either 1, 1.5, 3 or 8, and clots were scored 1, 3 or 5, based on apparent size. Pictogram scored assessments were converted to approximate mL of blood. |
Countries
United States
Participant flow
Pre-assignment details
ZPU-003 EXT was an open-label extension study of ZPU-003 (NCT00882258) and all patients received active medication (25 mg of Proellex); results were summarized according to the following groups - subjects who previously received active drug, by dose (12.5 mg and 25 mg) and subjects who previously received placebo in the double-blind ZPU-003 study.
Participants by arm
| Arm | Count |
|---|---|
| Proellex 25 mg Participants received Proellex 25 mg by oral administration once per day in NCT00882258. In this extension study participants receive 25 mg Proellex by oral administration of two 12.5 mg capsules. PI discretion to decrease dose to 12.5mg if warranted. | 22 |
| Proellex 12.5 mg Then 25 mg Participants received Proellex 12.5 mg. capsule by oral administration once per day in NCT00882258. In this extension study participants receive 25 mg Proellex by oral administration of two 12.5 mg capsules. | 22 |
| Placebo, Then 25 mg Proellex Participants received Placebo capsule by oral administration once per day in NCT00882258. In this extension study participants receive 25 mg Proellex by oral administration of two 12.5 mg capsules. | 21 |
| Total | 65 |
Baseline characteristics
| Characteristic | Proellex 12.5 mg Then 25 mg | Placebo, Then 25 mg Proellex | Total | Proellex 25 mg |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants | 21 Participants | 65 Participants | 22 Participants |
| Age, Continuous | 42.6 years STANDARD_DEVIATION 5.38 | 40.6 years STANDARD_DEVIATION 6.48 | 41.6 years STANDARD_DEVIATION 5.78 | 41.5 years STANDARD_DEVIATION 5.55 |
| Region of Enrollment United States | 22 Participants | 21 Participants | 65 Participants | 22 Participants |
| Sex: Female, Male Female | 22 Participants | 21 Participants | 65 Participants | 22 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 19 / 22 | 18 / 22 | 19 / 21 |
| serious Total, serious adverse events | 2 / 22 | 1 / 22 | 1 / 21 |
Outcome results
Primary
The Change in Menorrhagia From the Baseline of ZPU-003 to the End of Each Off Drug Interval(ODI) Within the ZPU-003 Extension Study and the Baseline of ZPU-003 to the End of ZPU-003 Ext.
An ODI is defined as a time period of less than 3 months during which a return to menses occurs. All statistical endpoints will use the baseline of ZPU-003 Ext for 14-month data and baseline of ZPU-003 for 17-month data.
Time frame: Baseline to 17 months
Population: Intent to treat population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Proellex 25 mg | The Change in Menorrhagia From the Baseline of ZPU-003 to the End of Each Off Drug Interval(ODI) Within the ZPU-003 Extension Study and the Baseline of ZPU-003 to the End of ZPU-003 Ext. | Change from baseline to end of ODI 1 | -41.00 mL | Standard Deviation 71.63 |
| Proellex 25 mg | The Change in Menorrhagia From the Baseline of ZPU-003 to the End of Each Off Drug Interval(ODI) Within the ZPU-003 Extension Study and the Baseline of ZPU-003 to the End of ZPU-003 Ext. | Baseline | 136.29 mL | Standard Deviation 88.12 |
| Proellex 25 mg | The Change in Menorrhagia From the Baseline of ZPU-003 to the End of Each Off Drug Interval(ODI) Within the ZPU-003 Extension Study and the Baseline of ZPU-003 to the End of ZPU-003 Ext. | Change from baseline to end of ODI 2 | -38.60 mL | Standard Deviation 69.3 |
| Proellex 25 mg | The Change in Menorrhagia From the Baseline of ZPU-003 to the End of Each Off Drug Interval(ODI) Within the ZPU-003 Extension Study and the Baseline of ZPU-003 to the End of ZPU-003 Ext. | Change from baseline to end of ODI 4 | -48.00 mL | Standard Deviation 11.31 |
| Proellex 25 mg | The Change in Menorrhagia From the Baseline of ZPU-003 to the End of Each Off Drug Interval(ODI) Within the ZPU-003 Extension Study and the Baseline of ZPU-003 to the End of ZPU-003 Ext. | Change from baseline to 17 months | 1.43 mL | Standard Deviation 94.09 |
| Proellex 25 mg | The Change in Menorrhagia From the Baseline of ZPU-003 to the End of Each Off Drug Interval(ODI) Within the ZPU-003 Extension Study and the Baseline of ZPU-003 to the End of ZPU-003 Ext. | Change from baseline to end of ODI 3 | -7.00 mL | Standard Deviation 69.63 |
| Proellex 12.5 mg Then 25 mg | The Change in Menorrhagia From the Baseline of ZPU-003 to the End of Each Off Drug Interval(ODI) Within the ZPU-003 Extension Study and the Baseline of ZPU-003 to the End of ZPU-003 Ext. | Change from baseline to end of ODI 1 | -63.57 mL | Standard Deviation 100.83 |
| Proellex 12.5 mg Then 25 mg | The Change in Menorrhagia From the Baseline of ZPU-003 to the End of Each Off Drug Interval(ODI) Within the ZPU-003 Extension Study and the Baseline of ZPU-003 to the End of ZPU-003 Ext. | Change from baseline to end of ODI 3 | -222.50 mL | Standard Deviation 121.62 |
| Proellex 12.5 mg Then 25 mg | The Change in Menorrhagia From the Baseline of ZPU-003 to the End of Each Off Drug Interval(ODI) Within the ZPU-003 Extension Study and the Baseline of ZPU-003 to the End of ZPU-003 Ext. | Baseline | 179.95 mL | Standard Deviation 119.83 |
| Proellex 12.5 mg Then 25 mg | The Change in Menorrhagia From the Baseline of ZPU-003 to the End of Each Off Drug Interval(ODI) Within the ZPU-003 Extension Study and the Baseline of ZPU-003 to the End of ZPU-003 Ext. | Change from baseline to end of ODI 2 | -33.33 mL | Standard Deviation 213.63 |
| Proellex 12.5 mg Then 25 mg | The Change in Menorrhagia From the Baseline of ZPU-003 to the End of Each Off Drug Interval(ODI) Within the ZPU-003 Extension Study and the Baseline of ZPU-003 to the End of ZPU-003 Ext. | Change from baseline to 17 months | -211.40 mL | Standard Deviation 148.06 |
| Placebo, Then 25 mg Proellex | The Change in Menorrhagia From the Baseline of ZPU-003 to the End of Each Off Drug Interval(ODI) Within the ZPU-003 Extension Study and the Baseline of ZPU-003 to the End of ZPU-003 Ext. | Baseline | 130.86 mL | Standard Deviation 147.1 |
| Placebo, Then 25 mg Proellex | The Change in Menorrhagia From the Baseline of ZPU-003 to the End of Each Off Drug Interval(ODI) Within the ZPU-003 Extension Study and the Baseline of ZPU-003 to the End of ZPU-003 Ext. | Change from baseline to end of ODI 3 | -31.29 mL | Standard Deviation 175.46 |
| Placebo, Then 25 mg Proellex | The Change in Menorrhagia From the Baseline of ZPU-003 to the End of Each Off Drug Interval(ODI) Within the ZPU-003 Extension Study and the Baseline of ZPU-003 to the End of ZPU-003 Ext. | Change from baseline to 17 months | 17.50 mL | Standard Deviation 192.88 |
| Placebo, Then 25 mg Proellex | The Change in Menorrhagia From the Baseline of ZPU-003 to the End of Each Off Drug Interval(ODI) Within the ZPU-003 Extension Study and the Baseline of ZPU-003 to the End of ZPU-003 Ext. | Change from baseline to end of ODI 2 | -9.90 mL | Standard Deviation 125.88 |
Secondary
Change From Baseline of ZPU-003 Ext to 14 Months and 17 Months in Subject's Menstrual Pictogram Scores (mL) (Subjects Evaluable for Menorrhagia Only)
Patient assessed all menstrual products used for bleeding during the month-long time period between study visits. For the total menstrual pictogram score, a lower score indicated less menstrual bleeding, a higher score indicated more menstrual bleeding. Over the course of a menstrual cycle, each pad was scored on an ordinal scale from 1 to 5, each tampon scored either 1, 1.5, 3 or 8, and clots were scored 1, 3 or 5, based on apparent size. Pictogram scored assessments were converted to approximate mL of blood.
Time frame: Baseline, 14 months, 17 months
Population: Intent to treat population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Proellex 25 mg | Change From Baseline of ZPU-003 Ext to 14 Months and 17 Months in Subject's Menstrual Pictogram Scores (mL) (Subjects Evaluable for Menorrhagia Only) | Change from baseline to month 14 | -150.67 mL of Blood | Standard Deviation 66.89 |
| Proellex 25 mg | Change From Baseline of ZPU-003 Ext to 14 Months and 17 Months in Subject's Menstrual Pictogram Scores (mL) (Subjects Evaluable for Menorrhagia Only) | Change from baseline to month 17 | -25.33 mL of Blood | Standard Deviation 48.01 |
| Proellex 12.5 mg Then 25 mg | Change From Baseline of ZPU-003 Ext to 14 Months and 17 Months in Subject's Menstrual Pictogram Scores (mL) (Subjects Evaluable for Menorrhagia Only) | Change from baseline to month 14 | -248.67 mL of Blood | Standard Deviation 174.37 |
| Proellex 12.5 mg Then 25 mg | Change From Baseline of ZPU-003 Ext to 14 Months and 17 Months in Subject's Menstrual Pictogram Scores (mL) (Subjects Evaluable for Menorrhagia Only) | Change from baseline to month 17 | -230.00 mL of Blood | Standard Deviation 240.02 |
| Placebo, Then 25 mg Proellex | Change From Baseline of ZPU-003 Ext to 14 Months and 17 Months in Subject's Menstrual Pictogram Scores (mL) (Subjects Evaluable for Menorrhagia Only) | Change from baseline to month 14 | -654.00 mL of Blood | — |