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Hormone Therapy

Oral Contraceptive + Sotagliflozin Interaction in Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by Lexicon Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Premenopausal females with a body mass index (BMI) between 18 and 32 kg/m2 (inclusive)
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 6 to day 8, day 55 to day 57, day 62 to day 64
Awards & highlights

Study Summary

This trial is testing whether taking a contraceptive with sotagliflozin affects how the body processes either medication.

Who is the study for?
This trial is for premenopausal women with a BMI of 18-32 who haven't used oral contraceptives in the last 15 days. Women can't join if they've used certain other contraceptives recently, are pregnant or breastfeeding, have significant health issues, or have had prior exposure to sotagliflozin.Check my eligibility
What is being tested?
The study tests how an oral contraceptive (norgestimate and ethinyl estradiol) interacts with sotagliflozin in healthy women. It's a two-way trial where participants will receive either the contraceptive alone or combined with sotagliflozin.See study design
What are the potential side effects?
Potential side effects may include those typical of oral contraceptives such as nausea, headaches, mood changes, and menstrual irregularities. Sotagliflozin could cause urinary tract infections, dehydration symptoms like dizziness or fainting.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a premenopausal woman with a BMI between 18 and 32.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 6 to day 8, day 55 to day 57, day 62 to day 64
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 6 to day 8, day 55 to day 57, day 62 to day 64 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Plasma concentration of norgestimate/ethinyl estradiol to evaluate protocol specified PK parameters
Plasma concentration of sotaglifozin to evaluate protocol specified PK parameters
Secondary outcome measures
Number of treatment emergent adverse events

Trial Design

3Treatment groups
Experimental Treatment
Group I: Treatment CExperimental Treatment1 Intervention
once daily dosing for 14 days of oral contraceptive, followed by coadministration with sotagliflozin once daily for 7 days
Group II: Treatment BExperimental Treatment1 Intervention
once daily dosing for 28 days
Group III: Treatment AExperimental Treatment1 Intervention
once daily dosing for 7 days, followed by 7-day washout
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
oral contraceptive
2006
Completed Phase 3
~100
Sotagliflozin
FDA approved

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Lexicon PharmaceuticalsLead Sponsor
63 Previous Clinical Trials
23,560 Total Patients Enrolled
Suman Wason, MDStudy DirectorLexicon Pharmaceuticals, Inc.
25 Previous Clinical Trials
16,928 Total Patients Enrolled

Media Library

Oral Contraceptive (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02494609 — Phase 1
Healthy Subjects Research Study Groups: Treatment A, Treatment B, Treatment C
Healthy Subjects Clinical Trial 2023: Oral Contraceptive Highlights & Side Effects. Trial Name: NCT02494609 — Phase 1
Oral Contraceptive (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02494609 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an age restriction for prospective participants of this experiment?

"As indicated by the inclusion criteria, only those between ages 18 and 45 may apply for this trial. Meanwhile, 50 trials are available to individuals under 18 years old while 372 studies welcome participants above 65."

Answered by AI

What past research has been conducted regarding oral contraceptive usage?

"Presently, there exists one live clinical trial evaluating oral contraceptives. This research is not yet in Phase 3 and involves two locations based in Dallas, Texas."

Answered by AI

What is the present enrollment of this medical experiment?

"This trial has ended its recruitment period, with the original post dated July 1st 2015 and the last edit occurring on February 29th 2016. However, there are currently 840 trials looking for participants without any health issues (hs) as well as one study related to oral contraceptives still actively seeking enrolments."

Answered by AI

Is this an unprecedented scientific investigation?

"Currently, there is just one active trial for oral contraceptives running in two cities and one nation. This research started back in 2015 by Lexicon Pharmaceuticals, with a 30 patient cohort that completed the Phase 1 approval phase. Since then, 43 studies have been executed to completion."

Answered by AI

Are there still openings available for participants in this clinical trial?

"This research is no longer taking on volunteers, as it was initially posted on the 1st of July 2015 and last updated on February 29th 2016. For those looking for other opportunities, there are currently 840 trials that need healthy participants and one trial recruiting people to test oral contraceptives."

Answered by AI

Has the Food and Drug Administration validated oral contraceptive as a viable medication?

"Taking into account its phase 1 status, with limited data to support both efficacy and safety, our team at Power rated the oral contraceptive's safety as a score of 1."

Answered by AI

Who is eligible to take part in this clinical investigation?

"This trial requires 30 test subjects of pre-menopausal age (18 to 45) and a Body Mass Index between 18 and 32 kg/m2. Moreover, potential patients must not have taken oral contraceptives 15 days prior to the initial dose of Period 1."

Answered by AI

Who else is applying?

What site did they apply to?
Lexicon Investigational Site
What portion of applicants met pre-screening criteria?
Met criteria

What questions have other patients asked about this trial?

Recent research and studies
clinicaltrials.govStudy
Oral Contraceptive DDI Study
2015. "Oral Contraceptive DDI Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02494609.
~3 spots leftby Apr 2025
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