Uterine LeiomyomataPhase 1/2NCT01069094
A Study of Progenta (CDB-4124) in Pre-menopausal Women With Symptomatic Leiomyomata
A Phase 1/2 study testing Progenta and Lucron Depot in people with Uterine Leiomyomata, run by Repros Therapeutics Inc. at 1 site in Poland.
Trial summary
A study of 3 doses of Progenta versus placebo versus Lucron Depot for treatment of leiomyomata. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Uterine Leiomyomata
- What is being tested?
- Progenta and Lucron Depot
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 sitePoland
- Study dates
- Jul 2004to Jan 2005
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Had at least one leiomyomata lesion that was identifiable and measurable by transvaginal ultrasound.
- Had a regular or steady menstrual cycle lasting from 24 to 36 days.
Who cannot join
- Post-menopausal
- Subject with documented endometriosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Dose lead-in PK Followed by a Randomized, Double-blinded, Controlled, Multiple Dose Study of the Selective Progesterone Receptor Modulator Progenta (CDB-4124) in Pre-menopausal Women With Symptomatic Leiomyomata
A study of 3 doses of Progenta versus placebo versus Lucron Depot for treatment of leiomyomata.
Read the detailed description
Three doses of Progenta (CDB4124 - 12.5, 25, 50 mg) versus placebo versus Lucron Depot (leuprolide acetate for depot suspension) was initiated in females with symptomatic leiomyomata. A single dose PK visit was conducted only for subjects randomized to the Progenta arm, between screening and visit 1. A second PK assessment was conducted at Visit 3 (one month on drug) to collect steady state data. Treatment period lasted for 3 months.
- Conditions
- Uterine Leiomyomata
- Being tested
- Progenta, Lucron Depot, Placebo
- Keywords
- Uterine fibroids
- Medical subject headings
- Myofibroma, Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProgentaDrug
Also called CDB-4124, Telapristone acetate
12.5 mg, administered as a once daily oral dose for 90 days.
ProgentaDrug
Also called CDB-4124, Telapristone acetate
25 mg, administered as a once daily oral dose for 90 days.
ProgentaDrug
Also called CDB-4124
50 mg, administered as a once daily oral dose for 90 days.
Lucron DepotDrug
Also called leuprolide acetate for depot suspension
3.75 mg IM monthly
PlaceboDrug
Administered as a once daily oral dose for 90 days.
| Study group | Role | What they receive |
|---|---|---|
| progenta 12.5 mg | Experimental | Progenta (CDB-4124) 12.5 mg capsule Receives: Drug: Progenta |
| progenta 25 mg | Experimental | Progenta (CDB-4124) 25 mg capsule Receives: Drug: Progenta |
| progenta 50 mg | Experimental | Progenta (CDB-4124) 50 mg capsule Receives: Drug: Progenta |
| Lucron Depot | Active comparator | Lucron Depot, Leuprolide acetate for depot suspension Receives: Drug: Lucron Depot |
| placebo | Placebo comparator | Placebo capsule Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the safety of Progenta when administered in pre-menopausal women with symptomatic leiomyomata.
Measured: 90 days
Secondary outcomes (1)
Determine the tolerability of three doses of Progenta (12.5 mg, 25 mg, and 50 mg) as compared to placebo and Lucron Depot (leuprolide acetate for depot suspension) in pre-menopausal women with symptomatic leiomyomata.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2010 (estimated)
- Study startJul 2004
- Primary completionJan 2005
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine LeiomyomataStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Repros Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ronald Wiehle, PhD, Study director, Repros Therapeutics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01069094
- Sponsor's protocol ID
- ZN-001
- Status last verified
- Jun 2014
- First submitted
- 12 Feb 2010
- Last updated
- 30 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Dose lead-in PK Followed by a Randomized, Double-blinded, Controlled, Multiple Dose Study of the Selective Progesterone Receptor Modulator Progenta (CDB-4124) in Pre-menopausal Women With Symptomatic Leiomyomata
- ClinicalTrials.gov ID
- NCT01069094
- Acronym / sponsor ID
- ZN-001
- Conditions
- Uterine Leiomyomata
- Keywords
- Uterine fibroids
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Repros Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2004
- Primary completion
- Jan 2005 (actual)
- Study completion
- Jan 2005 (actual)
- First posted
- 17 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study of 3 doses of Progenta versus placebo versus Lucron Depot for treatment of leiomyomata.
Detailed description
Three doses of Progenta (CDB4124 - 12.5, 25, 50 mg) versus placebo versus Lucron Depot (leuprolide acetate for depot suspension) was initiated in females with symptomatic leiomyomata. A single dose PK visit was conducted only for subjects randomized to the Progenta arm, between screening and visit 1. A second PK assessment was conducted at Visit 3 (one month on drug) to collect steady state data. Treatment period lasted for 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| progenta 12.5 mg | Experimental | Drug: ProgentaProgenta (CDB-4124) 12.5 mg capsule |
| progenta 25 mg | Experimental | Drug: ProgentaProgenta (CDB-4124) 25 mg capsule |
| progenta 50 mg | Experimental | Drug: ProgentaProgenta (CDB-4124) 50 mg capsule |
| Lucron Depot | Active comparator | Drug: Lucron DepotLucron Depot, Leuprolide acetate for depot suspension |
| placebo | Placebo comparator | Drug: PlaceboPlacebo capsule |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Had at least one leiomyomata lesion that was identifiable and measurable by transvaginal ultrasound.
- Had a regular or steady menstrual cycle lasting from 24 to 36 days.
Key exclusion criteria (2 listed)
- Post-menopausal
- Subject with documented endometriosis
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 |
|---|---|---|
| ProgentaAlso: CDB-4124, Telapristone acetate12.5 mg, administered as a once daily oral dose for 90 days. | Drug | progenta 12.5 mg |
| ProgentaAlso: CDB-4124, Telapristone acetate25 mg, administered as a once daily oral dose for 90 days. | Drug | progenta 25 mg |
| ProgentaAlso: CDB-412450 mg, administered as a once daily oral dose for 90 days. | Drug | progenta 50 mg |
| Lucron DepotAlso: leuprolide acetate for depot suspension3.75 mg IM monthly | Drug | Lucron Depot |
| PlaceboAdministered as a once daily oral dose for 90 days. | Drug | placebo |
Primary outcome
Assess the safety of Progenta when administered in pre-menopausal women with symptomatic leiomyomata.
Time frame: 90 days
1 secondary outcome
Determine the tolerability of three doses of Progenta (12.5 mg, 25 mg, and 50 mg) as compared to placebo and Lucron Depot (leuprolide acetate for depot suspension) in pre-menopausal women with symptomatic leiomyomata.
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2014.
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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.
Ronald Wiehle, PhD study director
Repros Therapeutics Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Progenta and Lucron Depot in people with Uterine Leiomyomata, run by Repros Therapeutics Inc. at 1 site in Poland.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 30 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assess the safety of Progenta when administered in pre-menopausal women with symptomatic leiomyomata. (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jun 2014.