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ContraceptionPhase 3NCT05461573

Efficacy, Safety, and Tolerability of LPRI-CF113 as an Oral Contraceptive in Females

A Phase 3 study testing Drospirenone in people with Contraception and Change in Bone Mineral Density, run by Insud Pharma at 47 sites in 2 countries.

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 study will be in two parts, Part A and Part B. The primary objective of Part A is to evaluate the contraceptive efficacy of LPRI-CF113. The secondary objective of Part A is to evaluate the safety and tolerability of LPRI-CF113. Read more about this study

Who is it for?
Ages 13 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Contraception, Change in Bone Mineral Density
What is being tested?
Drospirenone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,542 participants
Where
47 sitesin 2 countries
Study dates
2 Aug 2022to 27 May 2025
Phase
Phase 3
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 13 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Subjects must be willing and able to provide written informed consent (for adults) or assent (for adolescents <18 years of age) and comply with all study procedures, prohibitions, restrictions, and scheduled visits
  • Subjects must be female, healthy, sexually active, postmenarcheal, premenopausal, and of childbearing potential, between 13 and 45 years of age (inclusive at the time of screening) and at risk for pregnancy
  • Note: Childbearing potential is defined as subjects who are ovulating, premenopausal, and not surgically sterile (ie, have not undergone hysterectomy, salpingectomy, or bilateral oophorectomy). Subjects that have undergone unilateral oophorectomy will not be considered surgically sterile and may be included in the study
  • Note: Only subjects 18 to 45 years of age (inclusive at the time of screening) are eligible for inclusion in Part B
  • Subjects must be willing to have vaginal intercourse (with a genetically male partner) throughout the Treatment Period (ie, during each medication cycle) without using a secondary (eg, spermicides) or emergency method of contraception
  • Subjects must have a BMI of 18 kg/m2 or higher
Show all 15Show fewer
  • Subjects must have a systolic blood pressure of 159 mmHg or lower and a diastolic blood pressure of 99 mmHg or lower
  • Note: The median of 3 blood pressure measurements will be used for this criterion
  • Note: Subjects are required to rest for 5 minutes prior to the first blood pressure measurement and for 1 minute between subsequent measurements. Measurements done without appropriate preparation of the subject (excluding caffeine use, smoking, or excessive physical activity) should not be considered, and the measurement should be repeated upon appropriate preparation of the subject
  • Subjects must be regularly menstruating (with cycle length between 21 and 35 days) for at least 3 months prior to the signing of the Informed Consent Form
  • Note: Breastfeeding women can be included 6 weeks after delivery irrespective of menstrual cycles post-delivery
  • Subjects must agree to not use any secondary (eg, spermicides) or emergency contraceptive methods during the study period
  • Subjects must not be enrolled or plan to enroll in any other clinical study during the study period
  • Subjects must be willing to use the study drug (LPRI-CF113) for 13 (28-day) medication cycles, and be willing to use the provided diary
  • Subjects must generally be in good physical and mental health based on a medical history and a physical examination performed by the Investigator at screening

Who cannot join

  • PART A:
  • The subject is pregnant at the time of screening
  • The subject has a desire to become pregnant at the time of screening
  • Note: The subject will be asked if she has a desire for pregnancy at screening (and at each study visit). If a positive answer is given at screening, the subject will be excluded
  • The subject plans regular concomitant use of barrier contraceptive methods, spermicides, intrauterine device, other contraceptive measures, prohibited medications, and drugs contraindicated for study drug
  • The subject has an abnormal and clinically significant finding on pelvic, breast, or ultrasound examination at screening based on the judgment of the Investigator
Show all 115Show fewer
  • The subject has an abnormal and clinically significant finding on physical examination, clinical laboratory assessments (chemistry, hematology, urinalysis), or 12-lead ECG assessment based on the judgment of the Investigator
  • The subject has had less than 3 menstrual cycles after discontinuing dosing of depot medroxyprogesterone acetate (Depo-Provera®) or any combined injectable contraceptive (eg, Cyclofem®) prior to consent/assent. Those with spontaneous menses while on injectable contraceptive will be considered for inclusion
  • The subject has received any of the following:
  • A progestin-releasing intra-uterine device or contraceptive implant within 2 months prior to screening or
  • A beta-human chorionic gonadotropin (β-hCG) or co-medication containing β-hCG within 1 month prior to screening
  • The subject at the time of screening has a history of primary amenorrhea or secondary amenorrhea (with or without known etiology)
  • Note: Primary amenorrhea is defined as no menarche by 16 years of age with normal secondary sexual characteristics
  • Note: Secondary amenorrhea is defined as the absence of menses for 3 months in the setting of previously normal (ie, regular) menstruation
  • The subject has a current male sexual partner with a history of infertility, vasectomy, or bilateral orchiectomy
  • The subject has an abnormal Pap smear finding of low-grade squamous intraepithelial lesion or higher at screening or 6 months prior to screening. Subjects <21 years of age at screening do not require a Pap smear
  • Note: Human papilloma virus (HPV) testing, by polymerase chain reaction (PCR), will be performed only in the case of atypical squamous cells of undetermined significance (ASC-US). Subjects with ASC-US can be included if negative for high-risk HPV strains
  • Note: A historical Pap smear may be used for eligibility if performed within the past 6 months with results available
  • The subject has a history of uncontrolled medical illness (eg, the subject has an uncontrolled thyroid disorder and is not on a stable treatment regimen for 2 or more months)
  • The subject has a history of jaundice while taking hormonal contraceptives
  • The subject has a history of alcohol or substance use disorder within 12 months prior to screening. Alcohol abuse is defined as typical consumption of 14 or more alcoholic drinks weekly
  • Note: One drink of alcohol is equivalent to ½ pint of beer (285 mL), 1 glass of spirits (25 mL), or 1 glass of wine (125 mL)
  • The subject has a history or current evidence of clinically significant psychiatric illness, such as major depression or schizophrenia, that in the opinion of the Investigator contraindicates participation in the study
  • The subject has surgical procedures scheduled to occur during the study that would preclude use of contraceptives or require withdrawal of contraceptives
  • The subject has a history of an inherited or acquired disorder that predisposes the subject to venous or arterial thromboembolism (eg, factor V Leiden mutation, prothrombin mutation, presence of antiphospholipid antibodies)
  • The subject has received an investigational product within 3 months prior to screening
  • The subject has a history of using or currently uses any medications known to interfere with the efficacy of hormonal contraceptives, or other prohibited medications or products
  • Medications known to reduce the efficacy of hormonal contraceptives:
  • Barbiturates
  • Bosentan
  • Anticonvulsants (e.g., topiramate, phenytoin, carbamazepine, oxcarbazepine, felbamate, rufinamide)
  • Primidone
  • Rifampin
  • Human immunodeficiency virus peptidase inhibitors (e.g., ritonavir, nelfinavir)
  • Non-nucleoside reverse transcriptase inhibitors (e.g., nevirapine, efavirenz)
  • Griseofulvin
  • Products containing St. John's Wort (hypericum perforatum)
  • Other prohibited medications or products:
  • Rifabutin
  • Aprepitant
  • Hepatitis C treatments (eg, boceprevir, telaprevir)
  • Azole antifungals (eg, fluconazole, itraconazole, ketoconazole, voriconazole)
  • Macrolides (eg, clarithromycin, erythromycin)
  • Verapamil
  • Diltiazem
  • Cyclosporine
  • Lamotrigine
  • Sex hormones
  • Grapefruit juice
  • The subject has a history of severe or critical Coronavirus Disease 2019 (COVID-19) or has been hospitalized for COVID-19 within 3 months prior to screening
  • Note: Severe COVID-19 severity is defined as individuals who have SpO2 <94% on room air at sea level, a PaO2/FiO2 <300 mmHg, a respiratory rate >30 breaths/min, or lung infiltrates >50%
  • Note: Critical COVID-19 severity is defined as individuals who have respiratory failure, septic shock, and/or multiple organ dysfunction
  • The subject has any ongoing condition or history of medical illness that in the opinion of the Investigator may jeopardize the conduct of the study or impact screening
  • The subject is employed by the Sponsor, the Contract Research Organization (CRO), or the clinical facility (permanent, temporary contract worker, or designee responsible for the conduct of the study), or is a family member (spouse, parent, sibling, or child) of the Sponsor, CRO, or clinical facility employee
  • The subject has a known contraindication or hypersensitivity to ingredients or excipients of the study drug (LPRI-CF113)
  • The subject has a history of or is currently being treated for any of the following:
  • Renal insufficiency
  • Hepatic insufficiency
  • Adrenal insufficiency
  • Venous thromboembolism (ie, deep vein thrombosis, pulmonary embolism)
  • Arterial thromboembolism of cardiac origin (eg, valvular heart disease)
  • Cerebral vascular disease
  • Coronary artery disease
  • Diabetic vasculopathy
  • Headaches with focal neurological symptoms
  • Major surgery requiring more than 7 days of immobilization within 3 months prior to screening
  • Carcinoma of the breast
  • Estrogen or progestin sensitive malignancies
  • Abnormal vaginal bleeding in the 6 months prior to screening
  • Cholestatic jaundice during pregnancy
  • Liver tumor (benign or malignant)
  • Active liver disease
  • Rheumatoid arthritis
  • PART B:
  • The subject is <18 years of age, inclusive
  • The subject has a BMD Z-score of -1.5 at or lower at screening
  • The subject has a history of low-trauma fracture (eg, fracture from a fall from standing height). This does not include fractures of the fingers, toes, or skull
  • The subject has a history of medical conditions or procedures associated with low BMD. This includes the following:
  • Metabolic bone disease (eg, Paget's Disease of the bone, osteomalacia)
  • Collagen vascular disease (eg, Marfan syndrome, Ehlers-Danlos syndrome, osteogenesis imperfecta)
  • Malabsorptive disease (eg, inflammatory bowel disease, postgastrectomy syndrome)
  • Bariatric surgery (except gastric banding)
  • Abnormal bone mineral metabolism (eg, hypocalcemia/hypercalcemia, hypophosphatemia/hyperphosphatemia, hypomagnesemia)
  • The subject has a history of chronic (3 or more months) use within 12 months of screening of the following medications known to increase BMD:
  • Bisphosphonates
  • Denosumab
  • Teriparatide
  • Abaloparatide
  • Romosozumab
  • Calcitonin
  • Fluoride
  • Strontium
  • The subject has a history of chronic (3 or more months) use within 12 months of screening of the following medications known to decrease BMD:
  • Glucocorticoids administered orally, intravenously, or by inhalation.
  • Note: Subjects taking chronic oral or intravenous glucocorticoids (eg, prednisone >2.5 mg daily for 3 or more months) will have a washout period of 12 months
  • Depo-Provera.
  • Note: Subjects using Depo-Provera for 2 or more years will be excluded
  • Aromatase inhibitors within 2 years prior to screening
  • Raloxifene within 2 years prior to screening
  • Anticonvulsants (phenytoin, phenobarbital, carbamazepine, or valproate)
  • Protease inhibitors
  • Cyclosporine
  • Heparin
  • Warfarin
  • Thiazolidinediones
  • Sodium-glucose transporter protein 2 inhibitors
  • Tricyclic antidepressants
  • Proton pump inhibitors
  • Selective serotonin reuptake inhibitors within 3 months prior to screening
  • The subject has any of the following that may preclude accurate BMD measurement by DXA scan:
  • History of lumbar spine surgery
  • History of bilateral hip surgery
  • Surgical placement of metallic implant (eg, nails, clips, screws, rods, pins, wires)
  • Piercings that cannot be removed
  • Weight or height that exceeds the limit of DXA scan table

Trial locations and contacts

47 sites in 2 countries.

47 sites in 2 countries

United States46 sites

  • Alabama Clinical Therapeutics, LLC

    Alabaster, Alabama, 35007

  • Cornerstone Research Institute - Longwood

    Altamonte Springs, Florida, 32701

  • Central Texas Clinical Research

    Austin, Texas, 78705

  • Alabama Clinical Therapeutics, LLC

    Birmingham, Alabama, 35235

  • Encore Medical Research of Boynton Beach LLC.

    Boynton Beach, Florida, 33436

  • Chattanooga Medical Research

    Chattanooga, Tennessee, 37404

  • Women's Medical Research Group

    Clearwater, Florida, 33759

  • Clinohio Research Services

    Columbus, Ohio, 43213

  • Discovery Clinical Trials

    Dallas, Texas, 75225

  • The Research Center of the Upstate

    Greenville, South Carolina, 29607

  • Direct Helpers Research Center

    Hialeah, Florida, 33012

  • Inpatient Research Clinic, LLC

    Hialeah, Florida, 33013

  • Vital Pharma Research, Inc.

    Hialeah, Florida, 33016

  • Encore Medical Research, LLC

    Hollywood, Florida, 33021

  • Global Research Associates

    Homestead, Florida, 33030

  • TMC Life Research

    Houston, Texas, 77054

  • Clinical Research Prime

    Idaho Falls, Idaho, 83404

  • Leavitt Clinical Research

    Idaho Falls, Idaho, 83404

  • Rosemark WomenCare Specialists

    Idaho Falls, Idaho, 83404

  • Altus Research

    Lake Worth, Florida, 33461

  • FMC Science

    Lampasas, Texas, 76550

  • Maximos OB/GYN

    League City, Texas, 77573

  • Praetorian Pharmaceutical Research

    Marrero, Louisiana, 70072

  • Southern Clinical Research Associates

    Metairie, Louisiana, 70001

  • Florida International Medical Research

    Miami, Florida, 33155

  • New Age Medical Research Corporation

    Miami, Florida, 33186

  • SJ Research Institute

    Miami, Florida, 33186

  • Eastern Carolina Women's Center

    New Bern, North Carolina, 28562

  • Eastern Clinical Research Associates

    New Orleans, Louisiana, 70127

  • Eastern Virginia Medical School (EVMS)

    Norfolk, Virginia, 23507

  • Coastal Carolina Research Center

    North Charleston, South Carolina, 29405

  • Segal Institute for Clinical Research

    North Miami, Florida, 33161

  • American Research Centers of Florida

    Pembroke Pines, Florida, 33027

  • Austin Regional Clinic ARC Clinical Research at Kelly Lan

    Pflugerville, Texas, 78660

  • Clinical Research of Philadelphia

    Philadelphia, Pennsylvania, 19114

  • Unified Women's Clinical Research - Raleigh

    Raleigh, North Carolina, 27607

  • Virginia Women's Health Associates

    Reston, Virginia, 20190

  • Clinical Trials of Texas, LLC

    San Antonio, Texas, 78229

  • Fellows Research Alliance

    Savannah, Georgia, 31406

  • Mt. Olympus Medical Research- Sugar Land Texas

    Sugar Land, Texas, 77479

  • AC Clinical Research

    Tiffin, Ohio, 44883

  • Del Sol Research Management

    Tucson, Arizona, 85715

  • Eclipse Clinical Research

    Tucson, Arizona, 85745

  • Comprehensive Clinical Trials

    West Palm Beach, Florida, 33409

  • Encore Medical Research of Weston LLC

    Weston, Florida, 33331

  • Unified Women's Clinical Research - Winston-Salem

    Winston-Salem, North Carolina, 27103

Other trials in United States

Canada1 site

  • Clinique RS

    Québec, G1V 3M7

Other trials in Canada

About this study

Official title: A Phase 3, Multi-Center, Non-Comparative Study to Evaluate the Contraceptive Efficacy, Safety, and Tolerability of LPRI-CF113 Administered Orally for 13 Medication Cycles

This study will be in two parts, Part A and Part B. The primary objective of Part A is to evaluate the contraceptive efficacy of LPRI-CF113. The secondary objective of Part A is to evaluate the safety and tolerability of LPRI-CF113. The primary objective of Part B is to evaluate the impact of LPRI-CF113 on bone mineral density (BMD) at the lumbar spine (L1-L4) after 12 months (13 medication cycles). The secondary objective of Part B is to evaluate the impact of LPRI-CF113 on BMD and bone turnover after 12 months (13 medication cycles) at the femoral neck, total hip, and total body.

Read the detailed description

This is a Phase 3, prospective, multi-center, open-label, non-comparative study in female subjects 13 to 45 years of age (inclusive) to determine the efficacy, safety, and tolerability of LPRI-CF113 administered orally for 13 (28-day) medication cycles (Part A). Healthy, sexually active female subjects of childbearing potential, who present to the clinic seeking contraception, will be enrolled in the study.

Part B will be an investigation of bone mineral density (BMD) at the lumbar spine and BMD and bone turnover at the femoral neck, total hip, and total body. Part B will consist of a subgroup of subjects enrolled in Part A (i.e., subjects that meet all of Part A inclusion criteria and none of Part A AND Part B exclusion criteria) who are 18 to 45 years of age (inclusive at the time of screening). BMD will be assessed by dual-energy X-ray absorptiometry (DXA) scan.

The study duration (Parts A and B) for each subject will be up to approximately 404 days (28 days [screening] + 376 days [Treatment and Follow-up Period]), unless the subject meets criteria for the extended Part B Follow-up, in which the duration will be approximately 769 days (28 days [screening] + 376 days [Treatment and Follow-up Period] + 365 days [extended Part B Follow up]).

Being tested
Drospirenone
Keywords
Contraceptive Method Switching
Medical subject headings
Contraception Behavior

What participants receive

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

  • DrospirenoneDrug

    Also called LPRI-CF113

    LPRI-CF113 consists of 24 active white tablets containing drospirenone (DRSP) 4 mg followed by 4 active pink tablets containing DRSP 2.8 mg, taken orally once daily for 28 consecutive days, in consecutive cycles for 12 months (13 medication cycles) without a break in daily tablet intake.

Study groups in NCT05461573
Study groupRoleWhat they receive
Part A - An investigation of the efficacy, safety, and tolerability of LPRI-CF113ExperimentalAll subjects enrolled in the study will participate in Part A of the study. Part A of the study will investigate the efficacy, safety, and tolerability of LPRI-CF113.
Receives: Drug: Drospirenone
Part B - The effect of LPRI-CF113 on bone mineral density in a subgroup age 18-45ExperimentalA subgroup of subjects from Part A that are age 18-45 and without further exclusion criteria to Part B will be enrolled in Part B of the study. Part B of the study will investigate the effects of LPRI-CF113 on bone mineral density.
Receives: Drug: Drospirenone

What is being measured

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

  1. Part A (Efficacy Assessment): Number of pregnancies in subjects ≤35 years of age (at the time of screening).

    Calculated by Pearl Index.

    Measured: 12 months

Secondary outcomes (7)

  1. Part A (Efficacy Assessment): Number of pregnancies from exposure cycles in subjects ≤35 years of age.

    Calculated by Pearl Index.

    Measured: 12 months

  2. Part A (Efficacy Assessment): Number of pregnancies from method failures in subjects ≤35 years of age.

    Calculated by Pearl Index.

    Measured: 12 months

  3. Part A (Efficacy Assessment): Pregnancy ratio from evaluable cycles, exposure cycles, and perfect cycles in subjects ≤35 years of age.

    Calculated by life table analysis.

    Measured: 12 months

  4. Part A (Efficacy Assessment): Number of pregnancies from exposure cycles, method failures, and evaluable cycles in all subjects.

    Calculated by Pearl Index.

    Measured: 12 months

  5. Part A (Efficacy Assessment): Pregnancy ratio in all subjects.

    Calculated by life table analysis.

    Measured: 12 months

  6. Part A (Efficacy Assessment): Number of pregnancies from exposure cycles, method failures, and evaluable cycles in subjects >35 years of age.

    Calculated by Pearl Index.

    Measured: 12 months

  7. Part A (Efficacy Assessment): Pregnancy ratio in subjects >35 years of age.

    Calculated by life table analysis.

    Measured: 12 months

Timeline

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

  1. First posted18 Jul 2022
  2. Study start2 Aug 2022
  3. Primary completion5 Aug 2024
  4. Study completion27 May 2025

Resources

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 3
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Single group
Model description
All subjects enrolled in the study will participate in Part A of the study and receive the experimental drug LPRI-CF113 (drospirenone). Part A will investigate the efficacy, safety, and tolerability of LPRI-CF113. A subgroup of subjects that are age 18-45 and without further exclusion criteria to Part B will be enrolled in Part B of the study. Part B of the study will investigate the effects of LPRI-CF113 on bone mineral density.
Masking
None (open label)
Enrolment
1,542 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05461573
Sponsor's protocol ID
CF113-303
Status last verified
Oct 2025
First submitted
30 Jun 2022
Last updated
8 Oct 2025
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Rosenbaum P, Schmidt W, Helmerhorst FM, Wuttke W, Rossmanith W, Freundl F, Thomas K, Grillo M, Wolf A, Heithecker R. Inhibition of ovulation by a novel progestogen (drospirenone) alone or in combination with ethinylestradiol. Eur J Contracept Reprod Health Care. 2000 Mar;5(1):16-24. doi: 10.1080/13625180008500376.

    PubMed 10836659

  • SLYND (drospirenone) [prescribing information]. Florham Park, NJ. Exeltis USA, Inc. May 2019.

  • Investigator's Brochure for Drospirenone Only Pill - LF111. Edition No. 12.0, 18 March 2021.

  • Cibula D, Skrenkova J, Hill M, Stepan JJ. Low-dose estrogen combined oral contraceptives may negatively influence physiological bone mineral density acquisition during adolescence. Eur J Endocrinol. 2012 Jun;166(6):1003-11. doi: 10.1530/EJE-11-1047. Epub 2012 Mar 21.

    PubMed 22436400

  • Beksinska ME, Smit JA. Hormonal contraception and bone mineral density. Expert Rev of Obstet Gynecol. 2011;6(3):305-319.

  • Investigator's Brochure for Drospirenone 4 mg and 2.8 mg Oral Tablets - LPRI-CF113. Edition No. 2.2, 10 August 2022.

  • Thomas SL, Ellertson C. Nuisance or natural and healthy: should monthly menstruation be optional for women? Lancet. 2000 Mar 11;355(9207):922-4. doi: 10.1016/S0140-6736(99)11159-0. No abstract available.

    PubMed 10752720

  • Burkman R, Bell C, Serfaty D. The evolution of combined oral contraception: improving the risk-to-benefit ratio. Contraception. 2011 Jul;84(1):19-34. doi: 10.1016/j.contraception.2010.11.004. Epub 2010 Dec 24.

    PubMed 21664507

  • Bitzer J. Hormone withdrawal-associated symptoms: overlooked and under-explored. Gynecol Endocrinol. 2013 Jun;29(6):530-5. doi: 10.3109/09513590.2012.760194. Epub 2013 Feb 20.

    PubMed 23421366

  • Belsey EM, Machin D, d'Arcangues C. The analysis of vaginal bleeding patterns induced by fertility regulating methods. World Health Organization Special Programme of Research, Development and Research Training in Human Reproduction. Contraception. 1986 Sep;34(3):253-60. doi: 10.1016/0010-7824(86)90006-5.

    PubMed 3539509

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Drospirenone in people with Contraception and Change in Bone Mineral Density, run by Insud Pharma at 47 sites in 2 countries.

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 15 inclusion and 115 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 8 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 sites in United States, Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Part A (Efficacy Assessment): Number of pregnancies in subjects ≤35 years of age (at the time of screening). (time frame: 12 months). 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 NCT05461573, which also lists 10 linked publications.

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 8 Oct 2025.

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