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A Study to Investigate the Pharmacokinetics of a Combined Oral Contraceptive When Given Alone and in Combination With GSK3036656 in Female Participants of Non-childbearing Potential Aged 18 to 65 Years of Age

NCT06354257 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-08-26

Study results available
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Summary

The purpose of this study is to provide data showing if there are any effects of GSK3036656 on a combined oral contraceptive containing Ethinyl Estradiol (EE) and Levonorgestrel (LNG), which will help inform future studies on suitable contraceptive measures to be used.

Conditions

Interventions

DRUG

Microgynon

Participants received 1 dose of Microgynon (0.03 mg EE/0.15 mg LNG) on Day 1 of Treatment Period 1 and 1 dose co-administered with GSK3036656 20 mg on Day 15 of Treatment Period 3.

DRUG

GSK3036656

Participants received 1 loading dose of 40 mg on Day 4 and a dose of 20 mg on Days 5 to 14 once daily in Treatment Period 2. In Treatment Period 3, participants received one 20 mg dose along with Microgynon (0.03 mg EE/0.15 mg LNG) on Day 15 after which a 20 mg dose on Days 17 and 18 once daily.

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-05
Primary Completion
2024-07-01
Completion
2024-07-01

Countries

  • Spain

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06354257 on ClinicalTrials.gov