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

NCT06048536 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: MR-130A-01-TD-2001
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

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

Contraception

Outcome Measures

Primary Outcomes (2)

• Proportion of responder overall (subjects with no ovulation in both treatment cycles)

  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.

  56 days

• Proportion of responder in cycle (subjects with no ovulation in one of the treatment cycles)

  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.

  56 days

Secondary Outcomes (9)

• For assessment of ovarian activity, Hoogland and Skouby score frequency analysis will be provided for:

  56 days

• Corpus luteum function will be evaluated in subjects by using Landgren criteria in conjunction with Hoogland and Skouby score. Frequency analysis will be provided for:

  56 days

• The diameter of the largest FLS in both the right and left ovary will be measured (for each, the mean diameter from two directions). The largest of all follicles is considered the dominant FLS (FLSdom) for that study day.

  56 days

• The effect of cervical mucus will be calculated by Insler score. The subject-wise maximum Insler score (ISmax) will be calculated for each treatment cycle and for the entire treatment period.

  56 days

• To assess the effects of MR-130A-01 on sexual hormones(estradiol [E2], progesterone [P]) hormone concentrations determined in serum

  56 days

Study Arms (7)

Norelgestromin low dose 2.43mg 28/0 regimen non-Obese

EXPERIMENTAL

Drug: MR-130A-01 Transdermal patch

Norelgestromin mid dose 3.64mg 28/0 regimen non-Obese

EXPERIMENTAL

Drug: MR-130A-01 Transdermal patch

Norelgestromin high dose 4.86mg 28/0 regimen non-Obese

EXPERIMENTAL

Drug: MR-130A-01 Transdermal patch

Norelgestromin high dose 4.86mg 21/7 regimen non-Obese

EXPERIMENTAL

Drug: MR-130A-01 Transdermal patch

Norelgestromin mid dose 3.64mg 28/0 regimen Obese

EXPERIMENTAL

Drug: MR-130A-01 Transdermal patch

Norelgestromin high dose 4.86mg 28/0 regimen Obese

EXPERIMENTAL

Drug: MR-130A-01 Transdermal patch

Norelgestromin high dose 4.86mg 21/7 regimen Obese

EXPERIMENTAL

Drug: MR-130A-01 Transdermal patch

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.

Norelgestromin low dose 2.43mg 28/0 regimen non-Obese

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Subjects must consent to use reliable non-hormonal contraceptive methods (male condoms, diaphragm, or heterosexual abstinence) throughout the study, unless the subject has a history of female sterilization or sterilization of the sexual partner.

You may not qualify if:

• 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.
• Known or suspected malignancy or history thereof.
• Has unexplained vaginal bleeding within the past 6 months suspicious for serious condition, or any abnormal bleeding which is expected to recur during the study (eg. bleeding from cervical polyp, recurrent bleeding after sex).
• History or presence of ischemic heart disease, coronary artery disease, myocardial infarction, stroke, other cerebrovascular diseases including transient ischemic attacks (TIAs).
• Known dyslipidemias with other known cardiovascular risk factors.
• History or presence of hypertension (including adequately controlled hypertension) or hypertension with vascular disease or elevated blood pressure (BP) defined as systolic BP ≥140 mm Hg or diastolic BP ≥90 mm Hg, measured in sitting position after at least 5 minutes of rest (a single reading of blood pressure level is not sufficient to classify a woman as hypertensive).
• Pulse rate \< 50 bpm or \> 90 bpm
• Presence of deep vein thrombosis/pulmonary embolism.

Sponsors & Collaborators

• Mylan Pharmaceuticals Inc: lead

Study Sites (1)

dinox GmbH

Berlin, Germany

Location

Study Officials

• Sandeep Jagtap

  Mylan Pharmaceuticals Private Limited (A Viatris Company)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: September 21, 2023
• Study Start: December 22, 2023
• Primary Completion: January 18, 2024
• Study Completion: January 18, 2024
• Last Updated: November 29, 2024

Record last verified: 2024-11

Locations

DE (1)