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Dose-Finding Study of PDC31 in Patients With Primary Dysmenorrhea

NCT ID: NCT01250587

Last Updated: 2012-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2012-06-30

Brief Summary

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The purpose of this study is to determine a safe and effective dose range for intravenous administration (infusion) of PDC31 by determining the maximum tolerated dose of PDC31 in patients with primary dysmenorrhea.

Detailed Description

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This is an open-label, multi-centre, dose-escalating first-in-human Phase I study of PDC31 in patients with primary dysmenorrhea aimed at determining the maximum tolerated dose (MTD) of PDC31 in this patient population.

Conditions

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Dysmenorrhea

Keywords

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Open label dose-finding Phase 1 study

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PDC31

Group Type EXPERIMENTAL

PDC31

Intervention Type DRUG

This study involves the sequential administration of PDC31 to 4 cohorts of patients. The dose will be escalated in the absence of dose-limiting toxicities. PDC31 is to be administered as a 3-hour continuous infusion.

Interventions

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PDC31

This study involves the sequential administration of PDC31 to 4 cohorts of patients. The dose will be escalated in the absence of dose-limiting toxicities. PDC31 is to be administered as a 3-hour continuous infusion.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Otherwise healthy females with a history of primary dysmenorrhea
* Using effective birth control excluding intrauterine contraceptive device (IUCD)
* Must be 18 years of age or older
* Must give written informed consent to participate in this study

Exclusion Criteria

* Patients with an intrauterine contraceptive device or using oral contraceptives within 3 months of treatment in this study
* Patients with confirmed pelvic inflammatory disease, endometriosis or adenomyosis
* Patients who are pregnant or who test positive at baseline or are at risk of becoming pregnant while on study
* Patients who are breastfeeding
* Patients with hepatic or renal function tests greater than the upper limit of normal and deemed clinically significant by the Investigator at screening
* Patients with a clinically significant medical or psychiatric disorder or a serious medical conditions within the past 6 months which in the opinion of the investigator, should prohibit participation in this study
* Patients who have been exposure to any investigational drug within 4 weeks prior to screening
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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PDC Biotech GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Innsbruck Medical University

Innsbruck, , Austria

Site Status

Medical University of Vienna

Vienna, , Austria

Site Status

University Hospital Hamburg-Eppendorf

Hamburg, , Germany

Site Status

University of Mainz

Mainz, , Germany

Site Status

Countries

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Austria Germany

References

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Bottcher B, Laterza RM, Wildt L, Seufert RJ, Buhling KJ, Singer CF, Hill W, Griffin P, Jilma B, Schulz M, Smith RP. A first-in-human study of PDC31 (prostaglandin F2alpha receptor inhibitor) in primary dysmenorrhea. Hum Reprod. 2014 Nov;29(11):2465-73. doi: 10.1093/humrep/deu205. Epub 2014 Aug 27.

Reference Type DERIVED
PMID: 25164021 (View on PubMed)

Other Identifiers

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PDC-3111

Identifier Type: -

Identifier Source: org_study_id