Last updated: 11/07/2018 18:33:24
An open-label, Within-Subject Study to Compare the Pharmacodynamics and Pharmacokinetics of an Oral Contraceptive Containing Levonorgestrel 100mg and Ethinyl Estradiol 20mg in Healthy Female Subjects When Administered Alone and Following Co-Administration of Alosetron 1mg BID Orally for 28 Days
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: An open-label, Within-Subject Study to Compare the Pharmacodynamics and Pharmacokinetics of an Oral Contraceptive Containing Levonorgestrel 100mg and Ethinyl Estradiol 20mg in Healthy Female Subjects When Administered Alone and Following Co-Administration of Alosetron 1mg BID Orally for 28 Days
Trial description: An open-label, Within-Subject Study to Compare the Pharmacodynamics and Pharmacokinetics of an Oral Contraceptive Containing Levonorgestrel 100mg and Ethinyl Estradiol 20mg in Healthy Female Subjects When Administered Alone and Following Co-Administration of Alosetron 1mg BID Orally for 28 Days
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Pharmacodynamics and Pharmacokinetics of Oral Contraceptives Co-administered with Alosetron, Koch K, Campenella C, C Baidoo, Manzo J, Ameen V, Kersey K, Dig Dis Sci,49(7-8);1244-1249,2004
Medical condition
Irritable Colon
Product
alosetron
Collaborators
Not applicable
Study date(s)
July 2000 to November 2000
Type
Not applicable
Phase
1
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2000-22-11
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Not applicable
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