Determination of the Lowest, Safe and Effective Dose of Proellex
27. juni 2014 oppdatert av: Repros Therapeutics Inc.
A Single-Blind, Placebo Run-in, Phase I/II Study Comparing Five Oral Doses of Proellex®
The purpose of this study is to determine the effects of five different doses of Proellex on menses, ovulation, liver function, and steady state exposure in women of reproductive age.
Studieoversikt
Detaljert beskrivelse
A phase I/II, 5 arm, single blind study, comparing five doses of Proellex to matching placebo in healthy adult female subjects of reproductive age.
Exposure to study drug will be for up to 10 weeks.
In-clinic pharmacokinetic (PK) assessments will be made on the first day of dosing and on the last day (week 10).
Office visits will occur every week to assess liver function and trough blood concentrations for Proellex and primary metabolite.
Daily vaginal bleeding diaries will be maintained during the course of the study.
A single blind run-in period of up to 56 days will begin the study to assess baseline menstrual patterns will be utilized.
Twelve subjects per treatment group (total 60 subjects) will be assigned to each dose.
New groups will not begin dosing until the previous dose group has completed.
Daily treatments will be either 1 mg, 3 mg, 6 mg, 9 mg, 12 mg Proellex.
A single blind run-in period using placebo will be incorporated to establish baseline parameters.
Studietype
Intervensjonell
Registrering (Faktiske)
52
Fase
- Fase 2
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Texas
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San Antonio, Texas, Forente stater, 78209
- ICON Devlopment Solutions
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 50 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Hunn
Beskrivelse
Inclusion Criteria:
- Ability to understand and provide a written informed consent.
Healthy adult females between 18 and 50 years of age. Included in this group are women with the following conditions, not currently receiving drug treatment:
- Excessive menstrual bleeding;
- Menstrual pain;
- Confirmed uterine fibroids; and
- Confirmed endometriosis
- Normal menstrual cycle of 26-32 days
- Agree not to attempt to become pregnant
- Agree to limit alcohol consumption to no more than 2 drinks per week and to avoid alcohol consumption within 48 hours of each visit
- Ability to swallow gelatin capsules Ability to complete a daily subject diary
- Willing to discontinue hormonal contraceptives and consent to use of double barrier contraceptive techniques over the course of the study.
- Has a negative pregnancy test at the Screening and Baseline visits An exception for the pregnancy test requirement will be granted for subjects reporting surgical sterilization in medical history
- A Body Mass Index (BMI) between 18 and 39 inclusive
- Is available for all treatment and follow-up visits
Exclusion Criteria:
- Subject is a post-menopausal woman, defined as either; six (6) months or more (immediately prior to screening visit) without a menstrual period, or prior hysterectomy and/or oophorectomy
- Subject is pregnant or lactating or is attempting or expecting to become pregnant during the 7 month study period
- Women with abnormal liver enzymes or liver disease.
- Subject previously participated in Proellex clinical trials: ZPE-201, ZPU-003, ZPU-301, ZPU-302, ZPU-303, ZPU-304, ZPU-305, and ZPU-307.
- Received an investigational drug in the 30 days prior to the screening for this study
- Women with a history of PCOS
- Concurrent use of any testosterone, progestin, androgen, estrogen, anabolic steroids, DHEA or hormonal products for at least 2 weeks prior to screening and during the study.
- Use of oral contraceptives or hormone releasing IUDs in the preceding 30 days. Use of Depo-Provera® in the preceding 6 months.
- Women currently using narcotics
- Women currently taking cimetidine or spironolactone
- Clinically significant abnormal findings on screening examination or any condition which in the opinion of the investigator would interfere with the participant's ability to comply with the study instructions or endanger the participant if she took part in the study
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: ARM 1
1 mg Proellex
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1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)
Andre navn:
|
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Eksperimentell: ARM 2
3 mg Proellex
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1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)
Andre navn:
|
|
Eksperimentell: ARM 3
6 mg Proellex
|
1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)
Andre navn:
|
|
Eksperimentell: ARM 4
9 mg Proellex
|
1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)
Andre navn:
|
|
Eksperimentell: ARM 5
12 mg proellex
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1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Induction Amenorrhea
Tidsramme: 10 weeks
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Induction of amenorrhea as determined by suppression of ovulation and/or menses, measured by using ovulation timing kits and daily diary for bleeding.
Five doses will be compared in an escalating-dose, to independent groups, to a run-in placebo treatment period.
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10 weeks
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Laura M Sterling, MD, ICON Development Solutions
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. august 2010
Primær fullføring (Faktiske)
1. mars 2012
Studiet fullført (Faktiske)
1. mars 2012
Datoer for studieregistrering
Først innsendt
20. august 2010
Først innsendt som oppfylte QC-kriteriene
20. august 2010
Først lagt ut (Anslag)
23. august 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
28. juli 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
27. juni 2014
Sist bekreftet
1. juni 2014
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ZP-204
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