- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06048536
Dose-finding Study of MR-130A-01 Contraceptive Transdermal Patch
An Open-label, Phase II, Dose-finding Study of Three Dose Strengths of MR-130A-01 Contraceptive Transdermal Patch in Healthy Pre-menopausal Women
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Erin R Larnerd
- Phone Number: 3045545844
- Email: Erin.Larnerd@viatris.com
Study Contact Backup
- Name: Laura F Zachwieja
- Phone Number: 304-680-0256
- Email: laura.zachwieja@viatris.com
Study Locations
-
-
-
Berlin, Germany
- Recruiting
- dinox GmbH
-
Contact:
- Corrina Draeger
- Phone Number: +49-30-440595-22
- Email: corrina.draeger@dinox.de
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
- 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.
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.
- 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.
- Has any comorbid condition that may require major surgery with prolonged immobilization during the study period.
- History or presence of migraine with aura.
- Presence of liver disease including severe (decompensated) cirrhosis, benign (e.g., hepatocellular adenoma) or malignant liver tumors.
- Chronic disease potentially necessitating organ transplantation during the anticipated course of the study.
- Subjects having any other known contraindication to progestin only contraception as defined by category 3 or 4 conditions per World Health Organization Medical eligibility
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Norelgestromin low dose 2.43mg 28/0 regimen non-Obese
|
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, containing 3.64 mg Norelgestromin, will be worn 28 days per cycle with no patch free period.
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 MR-130A-01 transdermal patch containing 4.86 mg Norelgestromin, will be worn 21 days with a 7-day patch free period.
|
Experimental: Norelgestromin mid dose 3.64mg 28/0 regimen non-Obese
|
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, containing 3.64 mg Norelgestromin, will be worn 28 days per cycle with no patch free period.
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 MR-130A-01 transdermal patch containing 4.86 mg Norelgestromin, will be worn 21 days with a 7-day patch free period.
|
Experimental: Norelgestromin high dose 4.86mg 28/0 regimen non-Obese
|
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, containing 3.64 mg Norelgestromin, will be worn 28 days per cycle with no patch free period.
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 MR-130A-01 transdermal patch containing 4.86 mg Norelgestromin, will be worn 21 days with a 7-day patch free period.
|
Experimental: Norelgestromin high dose 4.86mg 21/7 regimen non-Obese
|
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, containing 3.64 mg Norelgestromin, will be worn 28 days per cycle with no patch free period.
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 MR-130A-01 transdermal patch containing 4.86 mg Norelgestromin, will be worn 21 days with a 7-day patch free period.
|
Experimental: Norelgestromin mid dose 3.64mg 28/0 regimen Obese
|
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, containing 3.64 mg Norelgestromin, will be worn 28 days per cycle with no patch free period.
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 MR-130A-01 transdermal patch containing 4.86 mg Norelgestromin, will be worn 21 days with a 7-day patch free period.
|
Experimental: Norelgestromin high dose 4.86mg 28/0 regimen Obese
|
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, containing 3.64 mg Norelgestromin, will be worn 28 days per cycle with no patch free period.
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 MR-130A-01 transdermal patch containing 4.86 mg Norelgestromin, will be worn 21 days with a 7-day patch free period.
|
Experimental: Norelgestromin high dose 4.86mg 21/7 regimen Obese
|
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, containing 3.64 mg Norelgestromin, will be worn 28 days per cycle with no patch free period.
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 MR-130A-01 transdermal patch containing 4.86 mg Norelgestromin, will be worn 21 days with a 7-day patch free period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of responder overall (subjects with no ovulation in both treatment cycles)
Time Frame: 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.
|
56 days
|
Proportion of responder in cycle (subjects with no ovulation in one of the treatment cycles)
Time Frame: 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.
|
56 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
For assessment of ovarian activity, Hoogland and Skouby score frequency analysis will be provided for:
Time Frame: 56 days
|
Frequency analysis will be provided per treatment arm for each of the treatment cycles. |
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:
Time Frame: 56 days
|
|
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.
Time Frame: 56 days
|
From this, the subject-wise maximum FLS diameter (MFD) will be calculated separately for each treatment cycle and over both cycles.
The maximum endometrial thickness (ETmax) subject-wise will be calculated for each treatment cycle and for the entire treatment period using transvaginal ultrasound.
This will be reported per visit and for each of the treatment cycles
|
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.
Time Frame: 56 days
|
56 days
|
|
To assess the effects of MR-130A-01 on sexual hormones(estradiol [E2], progesterone [P]) hormone concentrations determined in serum
Time Frame: 56 days
|
Descriptive statistics will be given per treatment arm for: Concentrations of FSH, LH, E2, and P at each visit • Max FSH, max LH, max E2, mean E2, max P in each treatment cycle and over both cycles |
56 days
|
Steady state concentration of NGMN and norgestrel will be calculated per treatment arm by means of non-compartmental analysis.
Time Frame: 56 days
|
Descriptive statistics (N, arithmetic means, SD, medians, minimum, maximum geometric means, geometric CV) will be presented for all pharmacokinetic parameters, separately for each treatment and analyte.
|
56 days
|
Patch adhesion will be evaluated by both data subject diary and site personnel.
Time Frame: 56 days
|
Frequency analysis of patch adhesion scores will be provided per treatment arm
In addition, the following evaluations will be presented per treatment arm for each evaluation time-point (day/week):
|
56 days
|
Safety will be evaluated by TEAEs considering action taken, frequency, seriousness, intensity, relationship to the IMP, outcome as well as treatment.
Time Frame: 56 days
|
Evaluation will be described by absolute and relative frequency.
Tolerability will be evaluated by application site reactions.
Frequency analysis of skin irritation categories will be provided per treatment arm over the entire treatment period.
|
56 days
|
Bleeding pattern will be assessed in each single subject over treatment cycle 1 and treatment cycle 2 (defined as 56-day reference period) by
Time Frame: 56 days
|
|
56 days
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Sandeep Jagtap, Mylan Pharmaceuticals Private Limited (A Viatris Company)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- MR-130A-01-TD-2001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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