Annovera™ Drug-Drug Interaction Study

Phase 1

Completed

• Conditions: Women; Contraception
• Interventions: Drug: Segesterone Acetate and Ethinyl Estradiol; Drug: Itraconazole; Drug: Rifampin

• Registration Number: NCT04290390
• Lead Sponsor: TherapeuticsMD

Brief Summary

A Drug-Drug Interaction (DDI) study to evaluate the effects of itraconazole and rifampin on the Pharmacokinetics of Segesterone Acetate and Ethinyl Estradiol from the Annovera Contraceptive Vaginal System (CVS)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-10
• Study Start: 2020-02-12
• Study First Submitted QC: 2020-02-27
• Study First Posted: 2020-02-28
• Status Verified: 2021-01
• Primary Completion: 2021-01-06
• Study Completion: 2021-01-06
• Last Update Submitted: 2021-01-28
• Last Update Posted: 2021-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 67

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Annovera (alone)	Segesterone Acetate and Ethinyl Estradiol	Annovera taken alone (without itraconazole or rifampin)
Annovera with itraconazole use	Segesterone Acetate and Ethinyl Estradiol	Subjects will dose with 200 mg/day of itraconazole for five days before Annovera insertion and through Days 1 to 8 of Annovera use
Annovera with itraconazole use	Itraconazole	Subjects will dose with 200 mg/day of itraconazole for five days before Annovera insertion and through Days 1 to 8 of Annovera use
Annovera with rifampin use	Segesterone Acetate and Ethinyl Estradiol	Subjects will dose with 600 mg/day rifampin for 8 days, between Days 4 to 11 of Annovera use during their respective treatment cycles
Annovera with rifampin use	Rifampin	Subjects will dose with 600 mg/day rifampin for 8 days, between Days 4 to 11 of Annovera use during their respective treatment cycles

Primary Outcome Measures

Name	Time	Method
Area-under-the-curve (AUC) of rifampin and itraconzaole on Annovera (segesterone acetate and ethinyl estradiol)	Day 1 for itraconazole cohort, Day 11 for rifampin cohort	AUC for 24 hours for segesterone acetate and ethinyl estradiol
Maximum concentration (Cmax) of rifampin and itraconzaole on Annovera (segesterone acetate and ethinyl estradiol)	Day 1 for itraconazole cohort, Day 11 for rifampin cohort	Cmax for segesterone acetate and ethinyl estradiol

Secondary Outcome Measures

Name	Time	Method
Safety - Number of Participants with Adverse Events	Screening through 14 days following Annovera removal	Serious adverse events (SAEs) and adverse events (AEs)
Safety - Vital signs - systolic and diastolic blood pressure	Through study completion, an average of 4 months	Measurements of systolic and diastolic blood pressure will be compared from Screening to end of treatment/end of study
Safety - Vital signs - pulse	Through study completion, an average of 4 months	Measurements of pulse will be compared from Screening to end of treatment/end of study
Tolerability -Discontinuation rates	Through study completion, an average of 4 months	Participant rates of discontinuation due to AEs will provide information regarding tolerability

Trial Locations

Locations (1)

Syneos Health; 🇨🇦 Quebec City, Quebec, Canada