A Drug-drug Interaction Study to Investigate the Effects of AZD1981 on the Metabolism and Pharmacodynamics of Oral Contraceptives

Study identifier:D9830C00015

ClinicalTrials.gov identifier:N/A

EudraCT identifier:2010-018864-18

CTIS identifier:N/A

Study Complete

Official Title

A Phase I, Double-blind, Randomised, Placebo-controlled, Two-cycle Crossover, Drug-drug Interaction Study to Investigate the Effects of AZD1981 Tablets 400 mg Twice Daily on the PK and PD of Oral Contraceptives in Healthy Female Volunteers

Medical condition

oral contraceptives

Phase

Phase 1

Healthy volunteers

Yes

Study drug

AZD1981, Neovletta 21/28, Placebo AZD1981

Sex

Female

Actual Enrollment

Study type

Interventional

Age

18 Years - 45 Years

Date

Study Start Date: 01 May 2010

Primary Completion Date: 01 Oct 2010

Study Completion Date: 01 Oct 2010

Study design

Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Basic Science

Verification:

Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Lulea, Sweden

Location

Research Site

Uppsala, Sweden

Arms	Assigned Interventions
Experimental: 1 AZD1981 + Oral contraceptive	Drug: AZD1981 4X100 mg per oral, twice daily for 28 days Drug: Neovletta 21/28 Once daily with (21) or without (28) pause for bleeding. Other Name: Neovletta 21/28
Placebo Comparator: 2 Placebo + Oral contraceptive	Drug: Neovletta 21/28 Once daily with (21) or without (28) pause for bleeding. Other Name: Neovletta 21/28 Drug: Placebo AZD1981 4X100 mg per oral, twice daily for 28 days

"There is no result for the study"

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=718&filename=CSR-D9830C00015.pdf
Download
CSR-D9830C00015.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

Quintiles Uppsala

+ 46 184311175

Investigators

Principal Investigator

Eva S Pettersson

AstraZeneca R&D

A Drug-drug Interaction Study to Investigate the Effects of AZD1981 on the Metabolism and Pharmacodynamics of Oral Contraceptives

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=718&filename=CSR-D9830C00015.pdf

CSR-D9830C00015.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator