Uterine FibroidsPhase 2NCT02811159

An Extension Study of 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids

A Phase 2 study testing Telapristone acetate in people with Uterine Fibroids, run by Repros Therapeutics Inc. at 8 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

To determine the safety of extended treatment with Proellex® in women who have successfully completed either study ZPV-201 [NCT02323646] or ZPU-203 [NCT02301897] and meet eligibility criteria. Read more about this study

Who is it for?: Ages 18 to 47 years, women only
Conditions the study is for: Uterine Fibroids
What is being tested?: Telapristone acetate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 8 sitesUnited States
Study dates: 26 Jul 2016to 4 May 2017
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 47 years
Women only
No healthy volunteers
Adult

Who may be able to join

Completed either study ZPV-201 [NCT02323646] or ZPU-203 [NCT02301897]
Agreement not to attempt to become pregnant during the trial
Agreement to use alcohol in moderation and record the daily consumption (note: elevated liver enzymes may result in discontinuation from the study)
Ability to complete a daily subject diary and study procedures in compliance with the protocol
Women of child-bearing potential must be willing to use double-barrier contraception during the study and off-drug intervals. Acceptable double-barrier methods are: male condom with spermicide; male condom with diaphragm; diaphragm containing spermicide plus additional intra-vaginal spermicide
Has a negative pregnancy test at Visit 1
Subject is available for all treatment and follow-up visits

Who cannot join

Subject had a significant decrease in bone mineral density while participating in ZPV-201 or ZPU-203 (total hip or spine measurement decreased by 5% or more)
Subject has undergone hysterectomy and/or bilateral oophorectomy since enrollment in ZPV-201 or ZPU-203
Subject is pregnant or lactating or is attempting or expecting to become pregnant during the entire study period
Subjects with abnormally high liver enzymes or liver disease. [alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeding 2 x upper limit of normal (ULN) and total bilirubin exceeding 1.5 x ULN at Visit 1 and confirmed on repeat].
Subject has a hemoglobin of <7.5 grams per deciliter (g/dL) at Visit 1
Concurrent use of any testosterone, progestin, androgen, estrogen, anabolic steroids, dehydroepiandrosterone (DHEA) or hormonal products for at least 2 weeks prior to Visit 1

Show all 16Show fewer

Use of oral contraceptives in the 30 days preceding screening. Use of Depo-Provera® in the preceding 10 months
Use of Gonadotrophin releasing hormone agonist (GnRHas) (e.g. Lupron Depot) within 3 months prior to screening (Lupron Depot must have a wash-out period of 3 months prior to screening)
Has an intra-uterine device (IUD) in place
Current cervical dysplasia classified as Atypical Squamous Cells of Undetermined Significance (ASCUS) associated with high-risk human papilloma virus (HPV)
Current diagnosis of Low/High Grade Squamous Intraepithelial Lesion (LGSIL or HGSIL), endometrial polyps or hyperplasia
Observation or history of abnormal endometrial biopsy including the presence of endometrial intraepithelial neoplasia (EIN)
Recent history (within past 6 months) of alcoholism or drug abuse
Endometrial stripe ≥18 mm in thickness at Visit 1 (subject may be enrolled with sponsor approval)
Subject is currently taking cimetidine or spironolactone or has taken them in the last 30 days
Clinically significant abnormal findings on Visit 1 examination and laboratory assessments or any condition which in the opinion of the investigator would interfere with the subject's ability to comply with the study instructions or endanger the subject if she took part in the study.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

Atlanta Women's Research Institute, Inc.
Atlanta, Georgia, 30342
KO Clinical Research, LLC
Fort Lauderdale, Florida, 33316
Advances in Health
Houston, Texas, 77030
The Women's Hospital of Texas Clinical Research Center
Houston, Texas, 77054
The Jackson Clinic, PA
Jackson, Tennessee, 38305
Southern Clinical Research Associates, LLC
Metairie, Louisiana, 70001
Clinical Research Partners, LLC
Richmond, Virginia, 23235
WR-Mount Vernon Clinical Research, LLC
Sandy Springs, Georgia, 30328

Other trials in United States

About this study

Official title: An Open-Label Extension Study of 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids

To determine the safety of extended treatment with Proellex® in women who have successfully completed either study ZPV-201 [NCT02323646] or ZPU-203 [NCT02301897] and meet eligibility criteria.

Read the detailed description

This study will be for participants who had completed either ZPV-201 or ZPU-203.

Conditions: Uterine Fibroids
Being tested: Telapristone acetate
Medical subject headings: Leiomyoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Telapristone acetateDrug
Also called Proellex®
Telapristone acetate, orally, once daily for three 18-weeks courses separated by an ODI.

Study groups in NCT02811159
Study group	Role	What they receive
Telapristone Acetate 12 mg	Experimental	Telapristone acetate 12 milligrams (mg), orally, once daily for two 18-weeks courses (Treatment Courses 1 and 2) separated by an off-drug interval (ODI). Receives: Drug: Telapristone acetate

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants in Amenorrhea
Amenorrhea was defined as no bleeding intensity score greater than 1 using the Daily Diary Card during the 28 days leading up to the last day of dosing at Week 18. Bleeding intensity was graded on a 5-point scale where: 0=no bleeding to 4=heavy bleeding.
Measured: At the end of 18 weeks Treatment Course 1
Percentage Change From Baseline in Total Uterine Fibroid System Quality of Life Survey System Severity (UFS-SSS) Score
UFS-SSS is an 8-question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. Each question was answered on a 5-point scale where 1=Not at all to 5=A very great deal. The sum of the total scores was transformed to a range of 0=no symptoms (best) to 100=most severe symptoms (worst). A negative percentage change from Baseline indicates improvement.
Measured: Baseline to the end of 18-weeks Treatment Course 1
Percentage Change From Baseline in the Individual UFS-SSS Subscale Score Question 1
UFS-SSS is an 8-question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 1: During the previous 3 months how distressed were you by "heavy bleeding during your menstrual period"? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement.
Measured: Baseline to the end of 18-weeks Treatment Course 1
Percentage Change From Baseline in the Individual UFS-SSS Subscale Score Question 2
UFS-SSS is an 8-question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 2: During the previous 3 months how distressed were you by "passing blood clots during your menstrual period"? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement.
Measured: Baseline to the end of 18-weeks Treatment Course 1
Percentage Change From Baseline in the Individual UFS-SSS Subscale Score Question 3
UFS-SSS is an 8-question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 3: During the previous 3 months how distressed were you by "fluctuation in the duration of your menstrual period compared to your previous cycle"? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement.
Measured: Baseline to the end of 18-weeks Treatment Course 1
Percentage Change From Baseline in the Individual UFS-SSS Subscale Score Question 4
UFS-SSS is an 8-question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 4: During the previous 3 months how distressed were you by "fluctuation in the length of your monthly cycle compared to your previous cycles"? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement.
Measured: Baseline to the end of 18-weeks Treatment Course 1
Percentage Change From Baseline in the Individual UFS-SSS Subscale Score Question 5
UFS-SSS is an 8-question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 5: During the previous 3 months how distressed were you by "feeling tightness or pressure in your pelvic area"? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement.
Measured: Baseline to the end of 18-weeks Treatment Course 1
Percentage Change From Baseline in the Individual UFS-SSS Subscale Score Question 6
UFS-SSS is an 8-question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 6: During the previous 3 months how distressed were you by "frequent urination during the daytime hours"? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement.
Measured: Baseline to the end of 18-weeks Treatment Course 1
Percentage Change From Baseline in the Individual UFS-SSS Subscale Score Question 7
UFS-SSS is an 8-question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 7: During the previous 3 months how distressed were you by "frequent night time urination"? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement.
Measured: Baseline to the end of 18-weeks Treatment Course 1
Percentage Change From Baseline in the Individual UFS-SSS Subscale Score Question 8
UFS-SSS is an 8-question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 8: During the previous 3 months how distressed were you by "feeling fatigued"? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement.
Measured: Baseline to the end of 18-weeks Treatment Course 1
Change From Baseline in Pictorial Blood Loss Assessment Chart (PBAC) Score
Uterine bleeding was assessed with the use of the PBAC, a validated self-reporting method to estimate menstrual blood loss. Participants recorded daily the number of tampons and towels used and the degree to which individual items were soiled with blood (plus small or large clots). Pictorial scores range from score 1 for slightly stained tampon/towel, 5 for a partially stained tampon/towel, 10 for a completely saturated tampon, 20 for a completely saturated towel, and 5 for each episode of flooding and for each blood clot larger than a quarter in size. Total score can range from 0 (no bleeding) to >500. Higher scores indicate more bleeding. Lower scores indicate less bleeding. A negative change from Baseline indicates improvement (reduction in bleeding).
Measured: Baseline to the end of 18-weeks Treatment Course 1
Percentage Change From Baseline in Total Uterine Fibroid Volume
The total uterine fibroid volume was measured by Magnetic Resonance Imaging (MRI). A negative percentage change from Baseline indicates improvement.
Measured: Baseline to the end of 18-weeks Treatment Course 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Jul 20164 May 2017

First posted23 Jun 2016 (estimated)
Study start26 Jul 2016
Primary completion4 May 2017
Study completion4 May 2017

Why it stopped: Business decision

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Uterine FibroidsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02811159
Sponsor's protocol ID: ZPU-203EXT
Status last verified: Jun 2019
First submitted: 21 Jun 2016
Last updated: 27 Jun 2019
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Prospective Study of TVRFA Treatment for FIGO Type 3-5 Uterine Fibroids
Leiomyoma (Uterine Fibroids)
RecruitingObservational study
Hereditary Leiomyomatosis Renal Cell Cancer - Study of the Genetic Cause and the Predisposition to Renal Cancer
Renal Tumor Histology, Cutaneous Leiomyoma
Active, not recruiting
Life Study: Lifestyle Intervention in Fibroid Elimination
Uterine Fibroid
Not yet recruiting
Office Hysteroscopy Versus Operating-room Hysteroscopy for Uterine Lesions
Uterine Polyps, Uterine Fibroids
RecruitingObservational study
Predictors of Success and Failure of v-NOTES Hysterectomy for Large and Very Large Uteri
Uterine Fibroids, Hysterectomy

All Uterine Fibroids trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label Extension Study of 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids
ClinicalTrials.gov ID: NCT02811159
Acronym / sponsor ID: ZPU-203EXT
Conditions: Uterine Fibroids
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Business decision
Enrolment: 20 participants (actual)
Lead sponsor: Repros Therapeutics Inc.Industry (pharma, biotech, devices)
Study start: 26 Jul 2016 (actual)
Primary completion: 4 May 2017 (actual)
Study completion: 4 May 2017 (actual)
First posted: 23 Jun 2016 (estimated)
Results: Posted 19 Jun 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To determine the safety of extended treatment with Proellex® in women who have successfully completed either study ZPV-201 [NCT02323646] or ZPU-203 [NCT02301897] and meet eligibility criteria.

Detailed description

This study will be for participants who had completed either ZPV-201 or ZPU-203.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Telapristone Acetate 12 mg	Experimental	Drug: Telapristone acetateTelapristone acetate 12 milligrams (mg), orally, once daily for two 18-weeks courses (Treatment Courses 1 and 2) separated by an off-drug interval (ODI).

Who may qualify

Ages: 18 to 47 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Completed either study ZPV-201 [NCT02323646] or ZPU-203 [NCT02301897]
Agreement not to attempt to become pregnant during the trial
Agreement to use alcohol in moderation and record the daily consumption (note: elevated liver enzymes may result in discontinuation from the study)
Ability to complete a daily subject diary and study procedures in compliance with the protocol
Women of child-bearing potential must be willing to use double-barrier contraception during the study and off-drug intervals. Acceptable double-barrier methods are: male condom with spermicide; male condom with diaphragm; diaphragm containing spermicide plus additional intra-vaginal spermicide

Key exclusion criteria (16 listed)

Subject had a significant decrease in bone mineral density while participating in ZPV-201 or ZPU-203 (total hip or spine measurement decreased by 5% or more)
Subject has undergone hysterectomy and/or bilateral oophorectomy since enrollment in ZPV-201 or ZPU-203
Subject is pregnant or lactating or is attempting or expecting to become pregnant during the entire study period
Subjects with abnormally high liver enzymes or liver disease. [alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeding 2 x upper limit of normal (ULN) and total bilirubin exceeding 1.5 x ULN at Visit 1 and confirmed on repeat].
Subject has a hemoglobin of <7.5 grams per deciliter (g/dL) at Visit 1

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Telapristone acetateAlso: Proellex®Telapristone acetate, orally, once daily for three 18-weeks courses separated by an ODI.	Drug	Telapristone Acetate 12 mg

Primary outcome

Percentage of Participants in Amenorrhea
Time frame: At the end of 18 weeks Treatment Course 1
Amenorrhea was defined as no bleeding intensity score greater than 1 using the Daily Diary Card during the 28 days leading up to the last day of dosing at Week 18. Bleeding intensity was graded on a 5-point scale where: 0=no bleeding to 4=heavy bleeding.
Percentage Change From Baseline in Total Uterine Fibroid System Quality of Life Survey System Severity (UFS-SSS) Score
Time frame: Baseline to the end of 18-weeks Treatment Course 1
UFS-SSS is an 8-question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. Each question was answered on a 5-point scale where 1=Not at all to 5=A very great deal. The sum of the total scores was transformed to a range of 0=no symptoms (best) to 100=most severe symptoms (worst). A negative percentage change from Baseline indicates improvement.
Percentage Change From Baseline in the Individual UFS-SSS Subscale Score Question 1
Time frame: Baseline to the end of 18-weeks Treatment Course 1
UFS-SSS is an 8-question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 1: During the previous 3 months how distressed were you by "heavy bleeding during your menstrual period"? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement.
Percentage Change From Baseline in the Individual UFS-SSS Subscale Score Question 2
Time frame: Baseline to the end of 18-weeks Treatment Course 1
UFS-SSS is an 8-question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 2: During the previous 3 months how distressed were you by "passing blood clots during your menstrual period"? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement.
Percentage Change From Baseline in the Individual UFS-SSS Subscale Score Question 3
Time frame: Baseline to the end of 18-weeks Treatment Course 1
UFS-SSS is an 8-question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 3: During the previous 3 months how distressed were you by "fluctuation in the duration of your menstrual period compared to your previous cycle"? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement.
Percentage Change From Baseline in the Individual UFS-SSS Subscale Score Question 4
Time frame: Baseline to the end of 18-weeks Treatment Course 1
UFS-SSS is an 8-question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 4: During the previous 3 months how distressed were you by "fluctuation in the length of your monthly cycle compared to your previous cycles"? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement.
Percentage Change From Baseline in the Individual UFS-SSS Subscale Score Question 5
Time frame: Baseline to the end of 18-weeks Treatment Course 1
UFS-SSS is an 8-question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 5: During the previous 3 months how distressed were you by "feeling tightness or pressure in your pelvic area"? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement.
Percentage Change From Baseline in the Individual UFS-SSS Subscale Score Question 6
Time frame: Baseline to the end of 18-weeks Treatment Course 1
UFS-SSS is an 8-question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 6: During the previous 3 months how distressed were you by "frequent urination during the daytime hours"? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement.
Percentage Change From Baseline in the Individual UFS-SSS Subscale Score Question 7
Time frame: Baseline to the end of 18-weeks Treatment Course 1
UFS-SSS is an 8-question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 7: During the previous 3 months how distressed were you by "frequent night time urination"? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement.
Percentage Change From Baseline in the Individual UFS-SSS Subscale Score Question 8
Time frame: Baseline to the end of 18-weeks Treatment Course 1
UFS-SSS is an 8-question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 8: During the previous 3 months how distressed were you by "feeling fatigued"? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement.
Change From Baseline in Pictorial Blood Loss Assessment Chart (PBAC) Score
Time frame: Baseline to the end of 18-weeks Treatment Course 1
Uterine bleeding was assessed with the use of the PBAC, a validated self-reporting method to estimate menstrual blood loss. Participants recorded daily the number of tampons and towels used and the degree to which individual items were soiled with blood (plus small or large clots). Pictorial scores range from score 1 for slightly stained tampon/towel, 5 for a partially stained tampon/towel, 10 for a completely saturated tampon, 20 for a completely saturated towel, and 5 for each episode of flooding and for each blood clot larger than a quarter in size. Total score can range from 0 (no bleeding) to >500. Higher scores indicate more bleeding. Lower scores indicate less bleeding. A negative change from Baseline indicates improvement (reduction in bleeding).
Percentage Change From Baseline in Total Uterine Fibroid Volume
Time frame: Baseline to the end of 18-weeks Treatment Course 1
The total uterine fibroid volume was measured by Magnetic Resonance Imaging (MRI). A negative percentage change from Baseline indicates improvement.

Results and safety

Results posted to the registry on 19 Jun 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Telapristone Acetate 12 mg	20	19

Primary outcome: Percentage of Participants in Amenorrhea

Time frame: At the end of 18 weeks Treatment Course 1. Number. Unit: percentage of participants

Measure	Telapristone Acetate 12 mg n = 20
Value	35.00

Telapristone Acetate 12 mg: p = 0.1797, Chi-Square Test

Population analysed: Intent-to-treat (ITT) population included all participants who received study drug.

Primary outcome: Percentage Change From Baseline in Total Uterine Fibroid System Quality of Life Survey System Severity (UFS-SSS) Score

Time frame: Baseline to the end of 18-weeks Treatment Course 1. Mean (Standard Deviation). Unit: percent change

Measure	Telapristone Acetate 12 mg n = 20
Value	-7.21 (20.046)

Telapristone Acetate 12 mg: p = 0.1250, Wilcoxon Signed-Rank Test

Population analysed: ITT population included all participants who received study drug.

Primary outcome: Percentage Change From Baseline in the Individual UFS-SSS Subscale Score Question 1

Time frame: Baseline to the end of 18-weeks Treatment Course 1. Mean (Standard Deviation). Unit: percent change

Measure	Telapristone Acetate 12 mg n = 20
Value	-10.50 (26.253)

Telapristone Acetate 12 mg: p = 0.2500, Wilcoxon Signed-Rank Test

Population analysed: ITT population included all participants who received study drug.

Primary outcome: Percentage Change From Baseline in the Individual UFS-SSS Subscale Score Question 2

Time frame: Baseline to the end of 18-weeks Treatment Course 1. Mean (Standard Deviation). Unit: percent change

Measure	Telapristone Acetate 12 mg n = 20
Value	-5.83 (18.157)

Telapristone Acetate 12 mg: p = 0.5000, Wilcoxon Signed-Rank Test

Population analysed: ITT population included all participants who received study drug.

Adverse events

Time frame: From first dose of study drug through 30 days after the last dose of study drug (approximately 43 weeks). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Telapristone Acetate 12 mg	1 of 20 (5%)	11 of 20 (55%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Uterine Fibroids

Active, not recruiting
Prospective Study of TVRFA Treatment for FIGO Type 3-5 Uterine Fibroids
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Hereditary Leiomyomatosis Renal Cell Cancer - Study of the Genetic Cause and the Predisposition to Renal Cancer
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Anna Chan study director

Allergan

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Telapristone acetate in people with Uterine Fibroids, run by Repros Therapeutics Inc. at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants in Amenorrhea (time frame: At the end of 18 weeks Treatment Course 1). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02811159.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2019.