Dose-finding Study of MR-130A-01 Contraceptive Transdermal Patch

What this trial studies

A single-center, randomized, open-label, parallel-group, multi-arm, phase II clinical trial in healthy women aged 18 to 35 years who have a documented ovulatory cycle prior to randomization.

Conditions in scope

• Contraception

Interventions

• MR-130A-01 Transdermal patch (Drug) — MR-130A-01 transdermal patch, containing 2.43 mg Norelgestromin, will be worn 28 days per cycle with no patch free period.
• MR-130A-01 Transdermal patch (Drug) — MR-130A-01 transdermal patch, containing 3.64 mg Norelgestromin, will be worn 28 days per cycle with no patch free period.
• MR-130A-01 Transdermal patch (Drug) — MR-130A-01 transdermal patch containing 4.86 mg Norelgestromin, will be worn 28 days per cycle with no patch free period
• MR-130A-01 Transdermal patch (Drug) — MR-130A-01 Transdermal patch MR-130A-01 transdermal patch containing 4.86 mg Norelgestromin, will be worn 21 days with a 7-day patch free period.

Who can join

Women only · Ages 18 Years to 35 Years · Accepts healthy volunteers.

Inclusion criteria

• Healthy, post-menarcheal and premenopausal women of age 18 to 35 years inclusive).
• BMI ≥18.0 kg/m2 at screening examination.
• Subjects must be in good physical and mental health as determined by vital signs, medical history, and physical and gynecological examination, as assessed by the investigator.
• Written informed consent, after having been informed about benefits and potential risks of the clinical trial, as well as details of the insurance taken out to cover the subject participating in the clinical trial.
• Status at least 3 months after a delivery, abortion, and stopping lactation, if applicable, before screening.
• Has regular menstrual cycles that are between 21 and 35 days in duration as reported by the subject during anamnesis, with an intact uterus and ovaries. If the subject uses hormonal birth control at screening, historic data should be used to evaluate this criterion.
• Both ovaries must be visible on TVUS examination during screening.
• Ovulatory pre-treatment cycle, as confirmed by a progesterone concentration \>10.0 nmol/L.

Exclusion criteria

• Known hypersensitivity or intolerance to any ingredient of the investigational product.
• History or presence of dermal sensitivity to medicated patches or to topical applications including bandages, surgical tape.
• Pregnancy or a positive serum beta human chorionic gonadotropin (β-hCG) pregnancy test at screening.
• Clinically relevant abnormal findings from serum biochemistry and hematology and HBsAg and Hepatitis C virus/human immunodeficiency virus (HIV) serology as evaluated by the investigator.
• ASAT (aspartate-aminotransferase) \> 20 % upper limit of normal (ULN), ALAT (alanine-aminotransferase) \> 10 % ULN, bilirubin \> 20% ULN (except in case of existing Morbus Gilbert-Meulengracht deduced from anamnesis/medical history) and creatinine \> 0.1 mg/dL ULN (limit of \> 0.1 mg/dL corresponds to \> 9 μmol/l ULN).
• Use of a non-hormonal intra-uterine device within the pre-treatment cycle or any hormonal contraception as follows:
• Short-acting hormonal contraceptives such as oral, patch, ring or intra-uterine systems within the menstrual cycle prior to the pre-treatment cycle.
• Injectable (intramuscularly or subcutaneously) within 10 months (three-month treatment duration), 6 months (two-month treatment duration) or 3 months (one-month treatment duration) prior to the start of pre-treatment cycle or implants within the menstrual cycle prior to the pre-treatment cycle.

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Completed
• Study type: Interventional
• Phase: PHASE2
• Start date: 2023-12-22
• Primary completion: 2024-01-18
• Last update posted: 2024-11-29
• First posted: 2023-09-21

Sponsor & contact

Lead sponsor: Mylan Pharmaceuticals Inc (Industry)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Proportion of responder overall (subjects with no ovulation in both treatment cycles) (56 days)
  A responder is a subject with no ovulation. A responder is a subject with no ovulation. Ovulation during treatment is defined as a Hoogland-Skouby score 5 or 6 in combination with fulfilment of Landgren criterion.
• Proportion of responder in cycle (subjects with no ovulation in one of the treatment cycles) (56 days)
  A responder is a subject with no ovulation. A responder is a subject with no ovulation. Ovulation during treatment is defined as a Hoogland-Skouby score 5 or 6 in combination with fulfilment of Landgren criterion.

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