Suzetrigine for Oral Contraceptive Interaction

Overseen By Medical Information

Age: 18 - 65

Sex: Female

Trial Phase: Phase 1

Sponsor: Vertex Pharmaceuticals Incorporated

Must be taking: Oral contraceptives

Disqualifiers: Hypertension, Cardiovascular disease, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

50 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have conditions that affect how drugs are absorbed or processed in your body, you might not be eligible to participate.

How does the drug Suzetrigine differ from other treatments for oral contraceptive interaction?

Suzetrigine is unique because it is being studied specifically for its interaction with oral contraceptives, which is not commonly the focus of other treatments. This makes it potentially novel in understanding and managing how it affects the effectiveness of birth control pills. ^{1 2 3 4 5}

What is the purpose of this trial?

The purpose of this study is to evaluate the effect of SUZ on the pharmacokinetics of oral contraceptives.

Eligibility Criteria

This trial is for healthy female participants who don't smoke or haven't smoked in the last year, have a body mass index (BMI) between 18.0 and 30.0, and weigh over 50 kilograms. It's designed to see how Suzetrigine affects the way their bodies process birth control pills.

Inclusion Criteria

My BMI is between 18.0 and 30.0.

I have not smoked for at least a year.

I weigh more than 50 kg.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Participants receive a single dose of DRSP/EE on Days 1 and 20, and SUZ every 12 hours from Days 7 through 25

4 weeks

Treatment Part B

Participants receive a single dose of NGM/EE on Days 1 and 22, and SUZ every 12 hours from Days 9 through 29

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Suzetrigine

Trial Overview The study is testing Suzetrigine (SUZ), a medication intended for pain management, to understand its impact on oral contraceptives specifically DRSP/EE and NGM/EE which are common forms of birth control pills.

Participant Groups

Group I: Part B: SUZ with Norgestimate/Ethinyl Estradiol (NGM/EE) Experimental Treatment 2 Interventions

Participants will receive a single dose NGM/EE on Days 1 and 22. Participants will also receive SUZ every 12 hours (q12h) from Days 9 through 29.

Group II: Part A: SUZ with Drospirenone/Ethinyl Estradiol (DRSP/EE) Experimental Treatment 2 Interventions

Participants will receive a single dose of DRSP/EE on Days 1 and 20. Participants will also receive SUZ every 12 hours (q12h) from Days 7 through 25.

Who Is Running the Clinical Trial?

Vertex Pharmaceuticals Incorporated

Lead Sponsor

Trials

267

Recruited

36,100+

Dr. David Altshuler

Vertex Pharmaceuticals Incorporated

Chief Medical Officer since 2020

MD, PhD

Dr. Reshma Kewalramani

Vertex Pharmaceuticals Incorporated

Chief Executive Officer since 2020

MD, trained in internal medicine and nephrology

Findings from Research

Co-administration of lamotrigine with a combined oral contraceptive significantly reduced the plasma levels of lamotrigine, indicating a clinically relevant pharmacokinetic interaction that may require dosage adjustments for lamotrigine.

While the combined oral contraceptive's effectiveness was not compromised (as indicated by unchanged ethinyloestradiol levels and maintained suppression of ovulation), a modest decrease in levonorgestrel levels was observed, along with reports of intermenstrual bleeding in some subjects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The pharmacokinetic and pharmacodynamic consequences of the co-administration of lamotrigine and a combined oral contraceptive in healthy female subjects. Sidhu, J., Job, S., Singh, S., et al.[2018]

In a study involving 35 HIV-infected women, those taking protease inhibitors (PI) showed significantly higher serum concentrations of norethindrone (NET), indicating that PIs inhibit the metabolism of this progestin-only contraceptive.

The findings suggest that progestin-only pills like NET may be more effective in HIV-infected women on PI regimens, as evidenced by a 1.5 times higher area under the curve for NET in the PI group compared to controls.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of protease inhibitors on steady-state pharmacokinetics of oral norethindrone contraception in HIV-infected women. Atrio, J., Stanczyk, FZ., Neely, M., et al.[2021]

In two studies involving 27 and 29 healthy women, oral tazarotene (up to 6 mg) did not significantly alter the pharmacokinetics of the oral contraceptive Ortho-Novum 1/35, indicating that tazarotene can be safely coadministered without affecting contraceptive efficacy.

The hormonal levels of norethindrone, ethinylestradiol, LH, and FSH remained within acceptable ranges, suggesting that tazarotene does not interfere with the hormonal balance maintained by the contraceptive, ensuring its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tazarotene does not affect the pharmacokinetics and efficacy of a norethindrone/ethinylestradiol oral contraceptive. Yu, Z., Yu, D., Walker, PS., et al.[2018]

Oral contraceptive steroids can have significant drug interactions, where certain medications, especially enzyme-inducing anticonvulsants like phenobarbital and rifampicin, can reduce the effectiveness of contraceptives, potentially leading to breakthrough bleeding or unintended pregnancy.

Conversely, some substances like ascorbic acid and paracetamol can increase blood levels of ethinylestradiol, the active component in many oral contraceptives, which may affect contraceptive efficacy, particularly in women taking high doses of these drugs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetic drug interactions with oral contraceptives. Back, DJ., Orme, ML.[2018]

Mothers taking combined oral contraceptives can safely breast-feed, as the concentrations of hormones like levonorgestrel and ethinylestradiol in breast milk are low.

Newer progestogens such as desogestrel, gestodene, and norgestimate show good bioavailability, but their effectiveness can be influenced by factors like sex hormone binding globulin (SHBG) levels and interactions with other medications, which may affect contraceptive efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical pharmacokinetics of contraceptive steroids. An update. Shenfield, GM., Griffin, JM.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

The pharmacokinetic and pharmacodynamic consequences of the co-administration of lamotrigine and a combined oral contraceptive in healthy female subjects. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Effect of protease inhibitors on steady-state pharmacokinetics of oral norethindrone contraception in HIV-infected women. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Tazarotene does not affect the pharmacokinetics and efficacy of a norethindrone/ethinylestradiol oral contraceptive. [2018]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Pharmacokinetic drug interactions with oral contraceptives. [2018]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical pharmacokinetics of contraceptive steroids. An update. [2018]