HealthyPhase 1NCT03401320

Evaluation of IM Letrozole ISM® Pharmacokinetics, Safety, and Tolerability in Healthy Post-menopausal Women (LISA-1)

A Phase 1 study testing Letrozole ISM in people with Healthy, run by Rovi Pharmaceuticals Laboratories at 1 site in Czechia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This is a Phase I, open label, dose escalation study designed to evaluate the pharmacokinetics, safety, and tolerability of single intramuscular injections of Letrozole ISM® at different strengths in voluntary healthy post menopausal women Read more about this study

Who is it for?: Ages 18 to 75 years, women onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Letrozole ISM
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 53 participants
Where: 1 siteCzechia
Study dates: 6 Nov 2017to 17 May 2024
Phase: Phase 1
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 75 years
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy post-menopausal women, ≥ 18 and ≤ 75 years of age, who have achieved complete menopause, either natural or surgical, and amenorrhea, and have not been on hormone replacement therapy in the last 3 months.
Post-menopausal subjects should have absence of menses for 1 year, and oophorectomized subjects should have absence of menses for at least 6 weeks. For oophorectomized subjects and subjects who have had a hysterectomy, a surgical pathology report documenting the absence of malignant disease is required. In addition, for oophorectomized subjects an operative report documenting bilateral oophorectomy is required.
Baseline follicle-stimulating hormone (FSH) and 17β-estradiol plasma levels should be consistent with the post-menopausal status of the subject (FSH ≥ 40 mIU/mL; 17β-estradiol ≤ 31 pg/mL), confirmed at least 48 hours prior to dosing.
Weight of ≥ 50 kg and a BMI ≥ 19 and ≤ 39 kg/m2.
Subjects will be in good health, as determined by medical history, physical examination, vital signs assessments (pulse rate, systolic and diastolic blood pressure, and temperature), clinical laboratory evaluations, and 12-lead ECG. Minor deviations outside the reference ranges will be acceptable, if deemed not clinically significant by the investigator.
Subjects who have not had a mammogram within the last 12 months (documentation required) must be willing to have one performed.

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Subjects with an intact uterus and cervix who have not had a Papanicolaou (pap) smear test within the last 6 months (documentation required) must be willing to have one performed.
Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions.
Subjects should be able to communicate with clinic staff.

Who cannot join

Subjects who have a history of allergy or hypersensitivity to letrozole or any of the inactive ingredients in the last 3 months.
Subjects who have a history of galactose intolerance, severe hereditary lactase deficiency glucose-galactose malabsorption.
Subjects who have used estrogen or progesterone hormone replacement therapy, thyroid replacement therapy, oral contraceptives, androgens, luteinizing hormone (LH) releasing hormone analogs, prolactin inhibitors, or antiandrogens within 3 months prior to Screening.
Subjects who have regularly taken foods or food supplements that contain high levels of Isoflavinoids, including soybean, soymilk, soynuts, chickpeas, alfalfa, fava beans, kudzu, miso and tofu in the 14 days prior to dosing (Treatment Period 1).
4.1. The investigator and medical monitor will determine on a case-by-case basis if a subject who intakes food or food supplements containing Isoflavinoids is eligible to participate in the study.
Subjects who have used:

Show all 31Show fewer

5.1. Any medications including St. John's wort, known to be potent or moderate inducers of CYP P450 3A4 in the 3 weeks prior to dosing (Treatment Period 1).
5.2. Any medications or products known to be potent or moderate inhibitors of CYP P450 3A4 (e.g. grapefruit juice) in the 7 days prior to dosing on Treatment Period 1.
Any prescribed preparations within 14 days prior to dosing (Treatment Period 1), unless in the opinion of the investigator (or designee) the medication will not interfere with the study procedures or compromise safety.
Any non-prescribed systemic or topical medications within 7 days of dosing (Treatment Period 1) unless in the opinion of the investigator (or designee) the medication will not interfere with the study procedures or compromise safety. Vitamins and minerals including the use of calcium and/or vitamin D for osteoporosis prevention are allowed.
Subjects who have been diagnosed with osteoporosis (previously or results from screening DEXA for this study with a T score < -2.5). Subjects with osteopenia (with the T-score between -1 and -2.5) will be allowed to participate in this study.
8.1. Subjects who are not on a stable dose of long- or short-acting bisphosphonates therapy for at least 3 months prior to Screening.
8.2. Subjects who are on raloxifene therapy.
Subjects who have an abnormality in heart rate, blood pressure, or temperature at Screening and prior to first dose (Treatment Period 1) that in the opinion of the investigator increases the risk of participating in the study. Resting SBP must be ≤ 150mmHg and resting DBP ≤ 95 mmHg.
Subjects who have an abnormality in the 12-lead ECG at Screening and prior to first dose (Treatment Period 1) that in the opinion of the Investigator increases the risk of participating in the study.
Subjects who have any clinically significant abnormal physical examination finding.
Subjects who have any clinically significant abnormal laboratory safety findings at Screening or Check-in, upon repeat testing, as determined by the investigator (1 repeat assessment is acceptable).
12.1. Subjects who have ALT or AST >1.5 × ULN. For subjects with elevated total bilirubin, direct and indirect bilirubin will be evaluated.
12.2. Subjects with elevated cholesterol or triglyceride levels above the ULN must be determined by the Investigator to be not clinically significant.
Subjects who have relevant diseases or clinically significant abnormal relevant findings at Screening, as determined by medical history, physical examination, laboratory, ECG, DEXA, and breast and pelvic examination.
Subjects who have history of any significant chronic disease, such as but not limited to: thrombotic disorders, coronary artery or cerebrovascular disease, liver, kidney or gallbladder dysfunction/disorder(s), diabetes or any other endocrine disease, estrogen dependent neoplasia, post-menopausal uterine bleeding, or endometrial hyperplasia. Subjects with cholecystectomy will be permitted if no medical sequelae post-surgery.
History of cancer within the past 5 years with the exception of non-melanoma skin cancer.
Subjects who have a history of drug-dependence, and recent history of alcoholism or abuse of alcohol.
Subjects who have a positive result for hepatitis B surface antigen (HBsAg), hepatitis B core antibody, hepatitis C antibody, or human immunodeficiency virus (HIV) antibodies.
Subjects with a positive drugs of abuse screen or alcohol breath test at Screening (urine will be screened for the presence of the following: amphetamine, barbiturates, benzodiazepines, cannabinoid, cocaine, opiates, phencyclidine, and methadone).
Subjects with a history of, or difficulty of, access to veins for venipuncture.
Subjects who have donated blood in the 30 days prior to first dose (Treatment Period 1).
Subjects who have received blood products within 2 months prior to Screening.
Subjects who have received a drug in research or have participated in other clinical trials within 30 days, or 5 half-lives (whichever is longer) prior to dosing (Treatment Period 1).
Subjects who have previously taken part in or have withdrawn from this study. (Subjects who have been screened for but not included in a cohort or subjects who dropped out from screening in a previous cohort for non-medical reasons may be eligible to be included in subsequent cohorts.)
Any other unspecified reason that, in the opinion of the investigator (or designee) or Sponsor, makes the subject unsuitable for enrollment.

Trial locations and contacts

1 site in 1 country.

Czechia1 site

Investigational Site Number 42001
Prague, Czech Republic, 10

Other trials in Czechia

About this study

Official title: A Phase I, Open Label, Dose Escalation Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Single Intramuscular Injections of Letrozole ISM® at Different Strengths in Voluntary Healthy Post Menopausal Women (LISA-1)

Read the detailed description

The objective of this study is to assess the pharmacokinetic profile of a single ascending doses of Letrozole ISM® (Rovi), and secondly, to evaluate safety and tolerability of single ascending doses of Letrozole ISM, measure estrogen levels, and characterize oral letrozole pharmacokinetic profile to be used in subsequent comparison to Letrozole ISM.

The study will be carried out in healthy post-menopausal women who satisfy inclusion and exclusion criteria.

The study consists of 3 treatment periods (TP) (TP1, TP2 and TP3) preceding by 2 Screening Periods (one for TP1 and one for TP3). In TP1, each subject will sequentially receive 1 dose daily of oral Femara (EU sourced) over a period of 14 days followed by a single intramuscular (IM) dose of Letrozole ISM (after a washout period) in TP2. Ascending doses of Letrozole ISM will be given sequentially to four Cohorts (1, 2, 3, and 4) [NOTE: Cohorts 3 and 4 were not finally performed because the Safety Review Committee considered it was not necessary for the achieving the objectives of the study] . All subjects who will finalize TP2 and fulfil the eligibility criteria will be offered to participate in TP3. The purpose is to have, at least, a minimum of 12 subjects receiving one oral daily dose of Femara (US sourced) 2.5 mg QD for a period of 14 days, to provide a complete pharmacokinetic (PK)/pharmacodynamic (PD) face-to-face comparison.

Conditions: Healthy
Being tested: Letrozole ISM
Keywords: pharmacokinetics, letrozole

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Letrozole ISMDrug
Also called Femara, 4,4'-(1H- 1,2,4-Triazol-1-ylmethylene)dibenzonitrile
2.5 mg Femara + single IM injection of 50-400 mg Letrozole ISM

Study groups in NCT03401320
Study group	Role	What they receive
Cohort 1: Letrozole ISM 50 mg	Experimental	14 oral doses of 2.5 mg Femara (once daily) + single IM injection of 50 mg Letrozole ISM Receives: Drug: Letrozole ISM
Cohort 2: Letrozole ISM 100 mg	Experimental	14 oral doses of 2.5 mg Femara (once daily) + single IM injection of 100 mg Letrozole ISM Receives: Drug: Letrozole ISM
Cohort 3: Letrozole ISM 200 mg	Experimental	14 oral doses of 2.5 mg Femara (once daily) + single IM injection of 200 mg Letrozole ISM Receives: Drug: Letrozole ISM
Cohort 4: Letrozole ISM 400 mg	Experimental	14 oral doses of 2.5 mg Femara (once daily) + single IM injection of 400 mg Letrozole ISM Receives: Drug: Letrozole ISM

What is being measured

The primary outcome is the main question the study is designed to answer.

λz
Terminal phase elimination rate constant
Measured: Following single intramuscular administration of Letrozole ISM (Period 2, Day 1)
Cmax
Maximum observed plasma concentration
Measured: Following single intramuscular administration of Letrozole ISM (Period 2, Day 1)
Cmax/D
Dose-normalized Maximum observed plasma concentration
Measured: Following single intramuscular administration of Letrozole ISM (Period 2, Day 1)
tmax
Time to maximum observed concentration
Measured: Following single intramuscular administration of Letrozole ISM (Period 2, Day 1)
tlag
Lag time before observation of quantifiable concentrations in plasma
Measured: Following single intramuscular administration of Letrozole ISM (Period 2, Day 1)
t½
Terminal elimination half life
Measured: Following single intramuscular administration of Letrozole ISM (Period 2, Day 1)
AUC∞
Area under the concentration time curve from time zero extrapolated to infinity
Measured: Following single intramuscular administration of Letrozole ISM (Period 2, Day 1)
AUC∞/D
Dose-normalized AUC∞
Measured: Following single intramuscular administration of Letrozole ISM (Period 2, Day 1)
AUCextrap
Percentage of AUC∞ obtained by extrapolation
Measured: Following single intramuscular administration of Letrozole ISM (Period 2, Day 1)
AUClast
Area under the concentration time curve from time zero up to the last quantifiable concentration
Measured: Following single intramuscular administration of Letrozole ISM (Period 2, Day 1)
Vz/F
Apparent volume of distribution during terminal phase after extravascular dosing
Measured: Following single intramuscular administration of Letrozole ISM (Period 2, Day 1)
CL/F
Apparent systemic clearance after extravascular dosing
Measured: Following single intramuscular administration of Letrozole ISM (Period 2, Day 1)

Secondary outcomes (11)

λz
Terminal phase elimination rate constant
Measured: Following multiple oral administrations of Femara (Period 1, Day 14)
Cav
Average plasma concentration over a dosing interval
Measured: Following multiple oral administrations of Femara (Period 1, Day 14)
Cmin,ss
Minimum observed plasma concentration at steady state
Measured: Following multiple oral administrations of Femara (Period 1, Day 14)
Cmax,ss
Maximum observed plasma concentration at steady state
Measured: Following multiple oral administrations of Femara (Period 1, Day 14)
tmax
Time to maximum observed concentration
Measured: Following multiple oral administrations of Femara (Period 1, Day 14)
t½
Terminal elimination half life
Measured: Following multiple oral administrations of Femara (Period 1, Day 14)
AUCτ
Area under the concentration time curve over a dosing interval
Measured: Following multiple oral administrations of Femara (Period 1, Day 14)
Vz/F
Apparent volume of distribution during terminal phase after extravascular dosing
Measured: Following multiple oral administrations of Femara (Period 1, Day 14)
CLss/F
Apparent systemic clearance after extravascular dosing at steady state
Measured: Following multiple oral administrations of Femara (Period 1, Day 14)
Hormones levels
The dose response relationship between doses letrozole and some hormones levels
Measured: From date of screening to follow-up visit, assessed up to 50 weeks
AEs
Incidence and severity of adverse events
Measured: From date of screening to follow-up visit, assessed up to 50 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Nov 201717 May 2024

First posted17 Jan 2018
Study start6 Nov 2017
Primary completion17 May 2024
Study completion17 May 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies 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 1
Primary purpose: Other
Allocation: Non-randomised
Intervention model: Sequential
Model description: Phase I, open label, sequential, single ascending dose
Masking: None (open label)
Enrolment: 53 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03401320
Sponsor's protocol ID: ROV-LET-2017-01
Other IDs: LISA-1
Status last verified: Nov 2024
First submitted: 8 Jan 2018
Last updated: 4 Dec 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Open Label, Dose Escalation Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Single Intramuscular Injections of Letrozole ISM® at Different Strengths in Voluntary Healthy Post Menopausal Women (LISA-1)
ClinicalTrials.gov ID: NCT03401320
Acronym / sponsor ID: ROV-LET-2017-01
Conditions: Healthy
Keywords: pharmacokinetics, letrozole
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 53 participants (actual)
Lead sponsor: Rovi Pharmaceuticals LaboratoriesIndustry (pharma, biotech, devices)
Study start: 6 Nov 2017 (actual)
Primary completion: 17 May 2024 (actual)
Study completion: 17 May 2024 (actual)
First posted: 17 Jan 2018 (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.

Detailed description

The study will be carried out in healthy post-menopausal women who satisfy inclusion and exclusion criteria.

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 4
Model description: Phase I, open label, sequential, single ascending dose

Arm	Type	Receives
Cohort 1: Letrozole ISM 50 mg	Experimental	Drug: Letrozole ISM14 oral doses of 2.5 mg Femara (once daily) + single IM injection of 50 mg Letrozole ISM
Cohort 2: Letrozole ISM 100 mg	Experimental	Drug: Letrozole ISM14 oral doses of 2.5 mg Femara (once daily) + single IM injection of 100 mg Letrozole ISM
Cohort 3: Letrozole ISM 200 mg	Experimental	Drug: Letrozole ISM14 oral doses of 2.5 mg Femara (once daily) + single IM injection of 200 mg Letrozole ISM
Cohort 4: Letrozole ISM 400 mg	Experimental	Drug: Letrozole ISM14 oral doses of 2.5 mg Femara (once daily) + single IM injection of 400 mg Letrozole ISM

Who may qualify

Ages: 18 to 75 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Healthy post-menopausal women, ≥ 18 and ≤ 75 years of age, who have achieved complete menopause, either natural or surgical, and amenorrhea, and have not been on hormone replacement therapy in the last 3 months.
Post-menopausal subjects should have absence of menses for 1 year, and oophorectomized subjects should have absence of menses for at least 6 weeks. For oophorectomized subjects and subjects who have had a hysterectomy, a surgical pathology report documenting the absence of malignant disease is required. In addition, for oophorectomized subjects an operative report documenting bilateral oophorectomy is required.
Baseline follicle-stimulating hormone (FSH) and 17β-estradiol plasma levels should be consistent with the post-menopausal status of the subject (FSH ≥ 40 mIU/mL; 17β-estradiol ≤ 31 pg/mL), confirmed at least 48 hours prior to dosing.
Weight of ≥ 50 kg and a BMI ≥ 19 and ≤ 39 kg/m2.
Subjects will be in good health, as determined by medical history, physical examination, vital signs assessments (pulse rate, systolic and diastolic blood pressure, and temperature), clinical laboratory evaluations, and 12-lead ECG. Minor deviations outside the reference ranges will be acceptable, if deemed not clinically significant by the investigator.

Key exclusion criteria (31 listed)

Subjects who have a history of allergy or hypersensitivity to letrozole or any of the inactive ingredients in the last 3 months.
Subjects who have a history of galactose intolerance, severe hereditary lactase deficiency glucose-galactose malabsorption.
Subjects who have used estrogen or progesterone hormone replacement therapy, thyroid replacement therapy, oral contraceptives, androgens, luteinizing hormone (LH) releasing hormone analogs, prolactin inhibitors, or antiandrogens within 3 months prior to Screening.
Subjects who have regularly taken foods or food supplements that contain high levels of Isoflavinoids, including soybean, soymilk, soynuts, chickpeas, alfalfa, fava beans, kudzu, miso and tofu in the 14 days prior to dosing (Treatment Period 1).
4.1. The investigator and medical monitor will determine on a case-by-case basis if a subject who intakes food or food supplements containing Isoflavinoids is eligible to participate in the study.

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
Letrozole ISMAlso: Femara, 4,4'-(1H- 1,2,4-Triazol-1-ylmethylene)dibenzonitrile2.5 mg Femara + single IM injection of 50-400 mg Letrozole ISM	Drug	Cohort 1: Letrozole ISM 50 mg, Cohort 2: Letrozole ISM 100 mg, Cohort 3: Letrozole ISM 200 mg, Cohort 4: Letrozole ISM 400 mg

Primary outcome

λz
Time frame: Following single intramuscular administration of Letrozole ISM (Period 2, Day 1)
Terminal phase elimination rate constant
Cmax
Time frame: Following single intramuscular administration of Letrozole ISM (Period 2, Day 1)
Maximum observed plasma concentration
Cmax/D
Time frame: Following single intramuscular administration of Letrozole ISM (Period 2, Day 1)
Dose-normalized Maximum observed plasma concentration
tmax
Time frame: Following single intramuscular administration of Letrozole ISM (Period 2, Day 1)
Time to maximum observed concentration
tlag
Time frame: Following single intramuscular administration of Letrozole ISM (Period 2, Day 1)
Lag time before observation of quantifiable concentrations in plasma
t½
Time frame: Following single intramuscular administration of Letrozole ISM (Period 2, Day 1)
Terminal elimination half life
AUC∞
Time frame: Following single intramuscular administration of Letrozole ISM (Period 2, Day 1)
Area under the concentration time curve from time zero extrapolated to infinity
AUC∞/D
Time frame: Following single intramuscular administration of Letrozole ISM (Period 2, Day 1)
Dose-normalized AUC∞
AUCextrap
Time frame: Following single intramuscular administration of Letrozole ISM (Period 2, Day 1)
Percentage of AUC∞ obtained by extrapolation
AUClast
Time frame: Following single intramuscular administration of Letrozole ISM (Period 2, Day 1)
Area under the concentration time curve from time zero up to the last quantifiable concentration
Vz/F
Time frame: Following single intramuscular administration of Letrozole ISM (Period 2, Day 1)
Apparent volume of distribution during terminal phase after extravascular dosing
CL/F
Time frame: Following single intramuscular administration of Letrozole ISM (Period 2, Day 1)
Apparent systemic clearance after extravascular dosing

11 secondary outcomes

λz
Time frame: Following multiple oral administrations of Femara (Period 1, Day 14)
Cav
Time frame: Following multiple oral administrations of Femara (Period 1, Day 14)
Cmin,ss
Time frame: Following multiple oral administrations of Femara (Period 1, Day 14)
Cmax,ss
Time frame: Following multiple oral administrations of Femara (Period 1, Day 14)
tmax
Time frame: Following multiple oral administrations of Femara (Period 1, Day 14)
t½
Time frame: Following multiple oral administrations of Femara (Period 1, Day 14)
AUCτ
Time frame: Following multiple oral administrations of Femara (Period 1, Day 14)
Vz/F
Time frame: Following multiple oral administrations of Femara (Period 1, Day 14)
CLss/F
Time frame: Following multiple oral administrations of Femara (Period 1, Day 14)
Hormones levels
Time frame: From date of screening to follow-up visit, assessed up to 50 weeks
AEs
Time frame: From date of screening to follow-up visit, assessed up to 50 weeks

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 4 Dec 2024.
Individual participant dataSharing planned: No

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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.

Javier Martínez, MD study director

Laboratorios Farmaceuticos Rovi, S.A.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Letrozole ISM in people with Healthy, run by Rovi Pharmaceuticals Laboratories at 1 site in Czechia.

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 31 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 4 Dec 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 Czechia. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

λz (time frame: Following single intramuscular administration of Letrozole ISM (Period 2, Day 1)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03401320.

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 4 Dec 2024; AzTrials last refreshed its copy on 8 Nov 2026.