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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01110525
Other study ID # D9830C00015
Secondary ID 2010-018864-18
Status Completed
Phase Phase 1
First received April 1, 2010
Last updated November 17, 2010
Start date May 2010
Est. completion date October 2010

Study information

Verified date November 2010
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Sweden: Medical Products Agency
Study type Interventional

Clinical Trial Summary

The primary purpose of this study is to determine whether the treatment with AZD1981 will affect the metabolism of hormones included in oral contraceptives.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date October 2010
Est. primary completion date October 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Females of childbearing potential

- Use of Neovletta or Neovletta 28 minimum 3 months prior to enrolment.

- Willing to use a highly effective method of birth control, ie, double barrier method contraception.

Exclusion Criteria:

- Pregnancy and/or lactation or delivery/abortion within 6 months prior to randomisation.

- Any clinically significant disease or disorder.

- Any clinically relevant abnormal findings in physical examination.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Drug:
AZD1981
4X100 mg per oral, twice daily for 28 days
Neovletta 21/28
Once daily with (21) or without (28) pause for bleeding.
Placebo AZD1981
4X100 mg per oral, twice daily for 28 days

Locations

Country Name City State
Sweden Research Site Lulea
Sweden Research Site Uppsala

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pharmacokinetics of of EE and LNG by analysis of the AUC and Css,max. PK sampling will be performed regularly during the study period of two months. No
Secondary Effect on LH, FSH, SHBG, progesterone, and E2 during the menstrual cycle: Serum concentrations of LH, FSH, SHBG, progesterone and E2 PD sampling will be done at the end of treatment period 1 and 2. No
Secondary Safety and tolerability of the combination: Adverse events, safety laboratory variables, pulse, blood pressure, electrocardiogram and physical examinations Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study. Yes
Secondary Steady state PK of 1981 in combo with oral contraceptives AUCt, Css,max, time to Cmax during a dosing interval (tmax ss);apparent plasma clearance (CLss/F) of AZD1981(tmax ss) of EE and LNG; Morning Ctrough values of EE and LNG will be measured. PK-sampling of AZD1981 wil be done at the end of treatment period 1 and 2. No
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Recruiting NCT02785809 - Ovarian Function and Reserve Parameters After Discontinuation of Long-term Use of Oral Contraception N/A