ContraceptionPhase 2NCT06048536
Dose-finding Study of MR-130A-01 Contraceptive Transdermal Patch
A Phase 2 study testing MR-130A-01 Transdermal patch in people with Contraception, run by Mylan Pharmaceuticals Inc at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- MR-130A-01 Transdermal patch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteGermany
- Study dates
- 22 Dec 2023to 18 Jan 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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:
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Phase II, Dose-finding Study of Three Dose Strengths of MR-130A-01 Contraceptive Transdermal Patch in Healthy Pre-menopausal Women
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.
Read the detailed description
MR-130A-01 is a progestin-only TDS containing NGMN as its progestin. NGMN is currently available in combination with EE in CHC TDSs Xulane® (US) and Evra® (EU), at doses of 150 mcg/day (Xulane® USPI 2022) and 203 mcg/day (Evra®SmPC 2022) respectively. In the currently planned dose-finding clinical trial the ovulation inhibition and the impact on further physiological functions and hormones of the three dose strengths of MR-130A-01 will be investigated in healthy pre-menopausal obese and non-obese women with ovulatory menstrual cycles. Eligible subjects will be randomized according to their body mass index (BMI) into one of 7 treatment arms with different doses and regimens of IMP administration. The IMPs which are transdermal patches, will be applied to the skin (upper outer arm, abdomen, buttock or back) and will be changed weekly. Depending on the treatment arm, either 4 or 3 patches of an allocated patch strength will be applied per cycle (28/0-day regimen and 21/7-day regimen). Patch adhesion will be assessed by the subjects daily and the results (adhesion scores) will be recorded in a diary. Throughout the clinical trial, ovarian activity will be monitored by TVUS, and blood samples will be collected for determination of progesterone (P), estradiol (E2), LH and FSH concentrations. The inhibition of ovulation will be assessed by Hoogland and Skouby Score (HSS). In addition, bleeding pattern will be assessed based on the subject's records of bleeding and its intensity in a diary.
- Conditions
- Contraception
- Being tested
- MR-130A-01 Transdermal patch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR-130A-01 Transdermal patchDrug
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 patchDrug
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 patchDrug
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 patchDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Norelgestromin low dose 2.43mg 28/0 regimen non-Obese | Experimental | Not described Receives: Drug: MR-130A-01 Transdermal patch |
| Norelgestromin mid dose 3.64mg 28/0 regimen non-Obese | Experimental | Not described Receives: Drug: MR-130A-01 Transdermal patch |
| Norelgestromin high dose 4.86mg 28/0 regimen non-Obese | Experimental | Not described Receives: Drug: MR-130A-01 Transdermal patch |
| Norelgestromin high dose 4.86mg 21/7 regimen non-Obese | Experimental | Not described Receives: Drug: MR-130A-01 Transdermal patch |
| Norelgestromin mid dose 3.64mg 28/0 regimen Obese | Experimental | Not described Receives: Drug: MR-130A-01 Transdermal patch |
| Norelgestromin high dose 4.86mg 28/0 regimen Obese | Experimental | Not described Receives: Drug: MR-130A-01 Transdermal patch |
| Norelgestromin high dose 4.86mg 21/7 regimen Obese | Experimental | Not described Receives: Drug: MR-130A-01 Transdermal patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 56 days
Secondary outcomes (9)
For assessment of ovarian activity, Hoogland and Skouby score frequency analysis will be provided for:
- Subjects with either HSS 5 or 6
- Subjects with HSS <5
- Subjects for each HSS from 1 to 6
- Subjects with HSS 5 or 6 and positive Landgren criterion
- Subjects with HSS 5 or 6 and negative Landgren criterion.
Frequency analysis will be provided per treatment arm for each of the treatment cycles.
Measured: 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:
- Subjects with HSS 5 or 6 and positive Landgren criterion
- Subjects with HSS 5 or 6 and negative Landgren criterion. Frequency analysis will be provided per treatment arm for each of the treatment cycles. Furthermore, frequency of occurrence of any Landgren criterion over both cycles will be calculated.
Measured: 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.
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
Measured: 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.
Measured: 56 days
To assess the effects of MR-130A-01 on sexual hormones(estradiol [E2], progesterone [P]) hormone concentrations determined in serum
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
Measured: 56 days
Steady state concentration of NGMN and norgestrel will be calculated per treatment arm by means of non-compartmental analysis.
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.
Measured: 56 days
Patch adhesion will be evaluated by both data subject diary and site personnel.
Frequency analysis of patch adhesion scores will be provided per treatment arm
- For each day of the application period of one patch (Day 1 to Day 7)
- For the subject-wise mean and maximum application score over the entire application period of one patch (1 week).
In addition, the following evaluations will be presented per treatment arm for each evaluation time-point (day/week):
- Proportion of subjects achieving greater than 90% adherence (score 0)
- Proportion of subjects with a meaningful degree of detachment (patch detachment ≥25% (estimated score ≥2)
- Number of patches that are completely detached (score 4).
Measured: 56 days
Safety will be evaluated by TEAEs considering action taken, frequency, seriousness, intensity, relationship to the IMP, outcome as well as treatment.
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.
Measured: 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
- Incidences (percentage of subjects) of unscheduled/scheduled bleeding and/or spotting episodes within the reference period
- The mean, median and range of number of observed days of bleeding and/or spotting within the reference period
- The observed days of bleeding and/or spotting within the reference period presented as total days, unscheduled days and scheduled days for bleeding and/or spotting, bleeding only and spotting only
- Incidences (percentage of subjects) of complete absence of bleeding or spotting during the reference period.
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start22 Dec 2023
- Primary completion18 Jan 2024
- Study completion18 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mylan Pharmaceuticals Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sandeep Jagtap, Study director, Mylan Pharmaceuticals Private Limited (A Viatris Company)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06048536
- Sponsor's protocol ID
- MR-130A-01-TD-2001
- Status last verified
- Nov 2024
- First submitted
- 8 May 2023
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Phase II, Dose-finding Study of Three Dose Strengths of MR-130A-01 Contraceptive Transdermal Patch in Healthy Pre-menopausal Women
- ClinicalTrials.gov ID
- NCT06048536
- Acronym / sponsor ID
- MR-130A-01-TD-2001
- Conditions
- Contraception
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Mylan Pharmaceuticals IncIndustry (pharma, biotech, devices)
- Study start
- 22 Dec 2023 (actual)
- Primary completion
- 18 Jan 2024 (actual)
- Study completion
- 18 Jan 2024 (actual)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
MR-130A-01 is a progestin-only TDS containing NGMN as its progestin. NGMN is currently available in combination with EE in CHC TDSs Xulane® (US) and Evra® (EU), at doses of 150 mcg/day (Xulane® USPI 2022) and 203 mcg/day (Evra®SmPC 2022) respectively. In the currently planned dose-finding clinical trial the ovulation inhibition and the impact on further physiological functions and hormones of the three dose strengths of MR-130A-01 will be investigated in healthy pre-menopausal obese and non-obese women with ovulatory menstrual cycles. Eligible subjects will be randomized according to their body mass index (BMI) into one of 7 treatment arms with different doses and regimens of IMP administration. The IMPs which are transdermal patches, will be applied to the skin (upper outer arm, abdomen, buttock or back) and will be changed weekly. Depending on the treatment arm, either 4 or 3 patches of an allocated patch strength will be applied per cycle (28/0-day regimen and 21/7-day regimen). Patch adhesion will be assessed by the subjects daily and the results (adhesion scores) will be recorded in a diary. Throughout the clinical trial, ovarian activity will be monitored by TVUS, and blood samples will be collected for determination of progesterone (P), estradiol (E2), LH and FSH concentrations. The inhibition of ovulation will be assessed by Hoogland and Skouby Score (HSS). In addition, bleeding pattern will be assessed based on the subject's records of bleeding and its intensity in a diary.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (20 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MR-130A-01 Transdermal patchMR-130A-01 transdermal patch, containing 2.43 mg Norelgestromin, will be worn 28 days per cycle with no patch free period. | Drug | Norelgestromin low dose 2.43mg 28/0 regimen non-Obese |
| MR-130A-01 Transdermal patchMR-130A-01 transdermal patch, containing 3.64 mg Norelgestromin, will be worn 28 days per cycle with no patch free period. | Drug | Norelgestromin mid dose 3.64mg 28/0 regimen Obese, Norelgestromin mid dose 3.64mg 28/0 regimen non-Obese |
| MR-130A-01 Transdermal patchMR-130A-01 transdermal patch containing 4.86 mg Norelgestromin, will be worn 28 days per cycle with no patch free period | Drug | Norelgestromin high dose 4.86mg 28/0 regimen Obese, Norelgestromin high dose 4.86mg 28/0 regimen non-Obese |
| MR-130A-01 Transdermal patchMR-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. | Drug | Norelgestromin high dose 4.86mg 21/7 regimen Obese, Norelgestromin high dose 4.86mg 21/7 regimen non-Obese |
Primary outcome
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.
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.
9 secondary outcomes
For assessment of ovarian activity, Hoogland and Skouby score frequency analysis will be provided for:
Time frame: 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
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
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
To assess the effects of MR-130A-01 on sexual hormones(estradiol [E2], progesterone [P]) hormone concentrations determined in serum
Time frame: 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
Patch adhesion will be evaluated by both data subject diary and site personnel.
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandeep Jagtap study director
Mylan Pharmaceuticals Private Limited (A Viatris Company)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MR-130A-01 Transdermal patch in people with Contraception, run by Mylan Pharmaceuticals Inc at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of responder overall (subjects with no ovulation in both treatment cycles) (time frame: 56 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024.