ContraceptionPhase 3NCT03945513
A Multicenter, Non-Comparative Trial on the Contraceptive Efficacy, Safety, and Tolerability of LPRI-424, 13 Cycles
A Phase 3 study testing LPRI424 (dienogest/ethinylestradiol) in people with Contraception, run by Insud Pharma at 1 site in United States.
Trial summary
The main objective of this trial is to demonstrate the contraceptive efficacy of LPRI424, Additional goals of the trial are to demonstrate the safety and tolerability of LPRI424. 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
- What is being tested?
- LPRI424 (dienogest/ethinylestradiol)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,034 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2019to 8 Sep 2023
- 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
- Sexually active, postmenarcheal and premenopausal female subjects at risk of pregnancy aged between 13-45 years (inclusive) (at the time of trial enrollment).
- Female subjects at risk of pregnancy aged between 13 and 17 years (inclusive) provided that:
- Applicable national, state and local laws allow subjects in this age group to consent/assent to receive contraceptive services,
- All applicable laws and regulations regarding the informed consent/assent of the subjects to participate in clinical trials are observed.
- Women who:
- have never used hormonal contraceptives before consent/assent (naïve users),
Show all 20Show fewer
- have used hormonal contraceptives in the past, but have had a hormonal contraceptive-free period before consent/assent and a full menstrual cycle during the drug-free period (previous users)
- directly switch from another hormonal contraceptive (switchers).
- Only for subjects who did not use hormonal contraception during the last six months before consent/assent: Regular cycles (i.e. cycle length between 24 and 35 days) during the last six months.
- At least three complete menstrual cycles after delivery pregnancy (only applicable for women who were pregnant within the last six months).
- At screening, maximum systolic blood pressure ≤ 140 mm Hg and diastolic blood pressure ≤ 90 mm Hg.
- Be able and willing to provide written informed consent or assent if the subject is adolescent, prior to undergoing any trial-related procedure.
- Willing to use trial contraception for thirteen 28-day cycles.
- Be willing to have intercourse in each cycle of the trial without the need to use back-up contraceptive.
- Be willing to state that, to her best knowledge, her male sexual partner(s):
- Has not had a vasectomy or been previously diagnosed as infertile.
- Has not been previously diagnosed or suspected of human immunodeficiency virus (HIV) unless he has subsequently had a negative HIV test.
- Has not been known to have engaged in homosexual intercourse in the past five years unless he has had negative HIV test results since then.
- Has not shared injection drug needles in the past unless he has had a negative HIV test at least six weeks since last use.
- Agree not to participate in any other clinical trials during the course of this trial (participation in a non-interventional study is allowed).
Who cannot join
- Pregnancy, wish for pregnancy, or breastfeeding subjects.
- Subject is known to or suspected of not being able to comply with the trial protocol, the use of the trial medication or the use of the trial diary.
- History of infertility.
- Abnormal finding on pelvic, breast or ultrasound examination that in the investigator's opinion contraindicates participation in the trial.
- Unexplained amenorrhea.
- Known polycystic ovary syndrome (PCOS).
Show all 51Show fewer
- Women ≥21 years of age with a Papanicolaou (pap) smear reading low-grade squamous intraepithelial lesion (LGSIL) or higher at screening (or six months prior to screening date). Subjects with atypical squamous cells of undetermined significance (ASC-US) can be included if they are negative for high-risk human papilloma virus (HPV) strains. Subjects <21 years of age do not require a pap smear.
- Known contraindication or hypersensitivity to ingredients or excipients of the IMP, including:
- Presence or risk of a venous thromboembolism (VTE)
- Venous thromboembolism - existing VTE (even under treatment with anticoagulants) or history of VTE* (e.g., deep venous thrombosis [DVT] or pulmonary embolism [PE])
- including a positive family history (VTE ever in a sibling or parent in particular at an age before 50 years)
- Known hereditary or acquired predisposition for VTE, e.g., activated protein C (APC) resistance (including Factor V Leiden), antithrombin III deficiency, protein C deficiency, protein S deficiency, or prothrombin-related thrombophilia
- Major surgery with prolonged periods of immobilization
- High risk of venous thromboembolism due to the presence of multiple risk factors
- Presence or risk of an arterial thromboembolism (ATE)
- Arterial thromboembolism - existing ATE, history of ATE (e.g., myocardial infarction) or prodromal condition (e.g., angina pectoris)
- Cerebrovascular disease - existing stroke, stroke or prodromal disorder (e.g., history of transient ischemic attack [TIA])
- Known hereditary or acquired predisposition for ATE, e.g., hyperhomocysteinemia and antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulants)
- History of migraine with focal neurological symptoms
- High risk of arterial thromboembolism due to multiple risk factors or to the presence of one serious risk factor such as diabetes mellitus with vascular damage, severe hypertension, severe dyslipoproteinemia, smokers or existing or previous pancreatitis, if it is associated with severe hypertriglyceridemia
- Existing or previous liver diseases in which liver function has not returned to normal (also Dubin-Johnson and Rotor syndrome)
- Existing or previous liver tumors
- Known or suspected sex hormone-dependent malignant tumors (e.g., breast or endometrium)
- Unexplained vaginal bleeding
- Hypersensitivity to the active ingredients or any of the excipients
- Concomitant use with the medicinal products containing ombitasvir/paritaprevir/ ritonavir and dasabuvir.
- Uncontrolled thyroid disorder (i.e., on stable dose of thyroid replacement for less than two months at the time of assent/consent).
- Uncontrolled concomitant diseases (i.e., not on a stable treatment dose for at least two months at the time of assent/consent).
- Evidence or history of alcohol, medication or drug abuse (within the last 12 months prior to consent/assent) or medication abuse (within the last three months prior to consent/assent).
- Predisposition bruising within the last 12 months prior to consent/assent.
- Known or suspected HIV, hepatitis and/or HPV infection (if the infection is due to aggressive strains) at screening.
- Less than 3 menses after discontinuing dosing of depot medroxyprogesterone acetate (DMPA or Depo-Provera®) or any combined injectable contraceptive (e.g., Cyclofem®) prior to consent/assent.
- Long-term treatment (longer than seven consecutive days within a month prior to V1b) of any medication that might interfere with the efficacy of hormonal contraceptives, e.g.:
- Anticonvulsants (e.g. phenytoin, carbamazepine, oxcarbazepine, topiramate, felbamate)
- Barbiturates (e.g. primidone)
- Some antibiotics (such as rifampicin)
- HIV medication (such as ritonavir, neviparine and efavirenz)
- Bosentan
- Griseofulvin
- St. John's wort (hypericum perforatum)
- Metoclopramide
- Prohibited medication including the regular intake or use of estrogens, progestogens, activated charcoal, microsomal enzyme-inducing drugs
- Administration of human chorionic gonadotropin (hCG) or intake of co-medication containing hCG within a month prior to V1b).
- Progestin-releasing intra-uterine device (IUD) or contraceptive implant received or in place within the last two months prior to consent/assent.
- Planned regular concomitant use of barrier contraceptive methods, spermicides, IUDs or other contraceptive measures (except occasional use for safety reasons, e.g., to reduce risk of infection).
- Evidence or history of clinically significant psychiatric illness, such as major depression or schizophrenia, that in the investigator's opinion contraindicates participation in the trialor suicide risk.
- Planned surgery during the anticipated time of participation in this trial requiring withdrawal of an oral contraceptive.
- Participation in another trial of an investigational drug or device parallel to the current trial or less than 90 days before consent/assent, or previous participation in the current trial and dispensed trial medication.
- Subject is a member of the investigator's or sponsor's staff or a relative or family member thereof.
- Any condition that, in the opinion of the investigator, may jeopardize protocol compliance or the scientific integrity of the trial.
- Severe COVID-10 disease or less than 3 months after hospitalization due to a COVID-19 disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fellows Research Alliance, Inc.
Savannah, Georgia, 31406
About this study
Official title: A Multicenter, Non-Comparative Trial on the Contraceptive Efficacy, Safety, and Tolerability of LPRI-424 (Dienogest 2 mg / Ethinyl Estradiol 0.02 mg) During 13 Cycles
The main objective of this trial is to demonstrate the contraceptive efficacy of LPRI424, Additional goals of the trial are to demonstrate the safety and tolerability of LPRI424.
Read the detailed description
This trial is a prospective, multicenter, open-label, non-controlled trial in postmenarcheal and premenopausal female subjects, including adolescents, between the ages of 13 and 45 who present to the clinic seeking contraception.
At screening, informed consent will be obtained and the screening procedures will be performed. After confirmation of the subject's eligibility, the subject will be provided with the investigational product and trained in the use of an electronic diary. Afterwards, the subjects will visit the clinical site on Day 20±3 of the 1st, 3rd, 6th and 9th cycles and on Day 29+3 of the 13th cycle. The last clinical site visit will occur 10-14 days after the 13th cycle visit.
The trial will include women who have never used hormonal contraceptives before consent (naïve users), women who have used hormonal contraceptives in the past but have had a contraceptive-free period before consent and a full menstrual cycle during the drug-free period (previous users) as well as women directly switching from another hormonal method (switchers).
Adverse events and safety information will be collected throughout the study.
- Conditions
- Contraception
- Being tested
- LPRI424 (dienogest/ethinylestradiol)
- Keywords
- contraception, hormonal oral contraceptive agents, hormonal oral contraceptive, oral contraceptive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LPRI424 (dienogest/ethinylestradiol)Drug
One LPRI424 tablet once per day for 24 days followed by 4 placebo tablets for 4 days equals one cycle.
| Study group | Role | What they receive |
|---|---|---|
| LPRI424 | Experimental | Dienogest 2 mg / ethinyl estradiol 0.02 mg tablet orally once daily for 24 days followed by 4 placebo tablets for a 28 day cycle, for 13 cycles Receives: Drug: LPRI424 (dienogest/ethinylestradiol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of pregnancies (evaluable cycles)
Pearl index (PI) from evaluable cycles in non-breastfeeding women aged ≤ 35 years (at the time of trial enrollment)
Measured: up to 13 months
Secondary outcomes (7)
Number of pregnancies (all)
Pearl Index based on overall cycles (overall PI) in women aged ≤ 35 years (at the time of trial enrollment)
Measured: up to 13 months
Number of pregnancies (method failures)
PI for method failures in women aged ≤ 35 years (at the time of trial enrollment)
Measured: up to 13 months
Pregnancy ratio
Pregnancy ratio in women aged ≤ 35 years (at the time of trial enrollment)
Measured: up to 13 months
Overall PI, PI for method failures in all women
Overall PI, PI for method failures, PI (using evaluable cycles) and pregnancy ratio (life table analysis) in all women
Measured: Up to 13 months
Overall PI, PI for method failures in women >35 years
- Overall PI, PI for method failures, PI (using evaluable cycles) and pregnancy ratio (life table analysis) in women aged > 35 years
Measured: Up to 13 months
Number of participants with adverse events as a measure of safety
Adverse events and changes in vital signs, clinical laboratory parameters
Measured: Up to 13 months
Tolerability; Vaginal bleeding pattern
Vaginal bleeding pattern
Measured: Up to 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study start3 Dec 2019
- Primary completion30 Jun 2023
- Study completion8 Sep 2023
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 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,034 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insud Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chemo Research
- Responsible party
- Sponsor
- Investigators
- Enrico Colli, MD, Study director, Chemo Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03945513
- Sponsor's protocol ID
- LPRI424/303
- Status last verified
- Nov 2023
- First submitted
- 9 May 2019
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Non-Comparative Trial on the Contraceptive Efficacy, Safety, and Tolerability of LPRI-424 (Dienogest 2 mg / Ethinyl Estradiol 0.02 mg) During 13 Cycles
- ClinicalTrials.gov ID
- NCT03945513
- Acronym / sponsor ID
- LPRI424/303
- Conditions
- Contraception
- Keywords
- contraception, hormonal oral contraceptive agents, hormonal oral contraceptive, oral contraceptive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,034 participants (actual)
- Lead sponsor
- Insud PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Chemo Research
- Study start
- 3 Dec 2019 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 8 Sep 2023 (actual)
- First posted
- 10 May 2019 (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.
The main objective of this trial is to demonstrate the contraceptive efficacy of LPRI424, Additional goals of the trial are to demonstrate the safety and tolerability of LPRI424.
Detailed description
This trial is a prospective, multicenter, open-label, non-controlled trial in postmenarcheal and premenopausal female subjects, including adolescents, between the ages of 13 and 45 who present to the clinic seeking contraception.
At screening, informed consent will be obtained and the screening procedures will be performed. After confirmation of the subject's eligibility, the subject will be provided with the investigational product and trained in the use of an electronic diary. Afterwards, the subjects will visit the clinical site on Day 20±3 of the 1st, 3rd, 6th and 9th cycles and on Day 29+3 of the 13th cycle. The last clinical site visit will occur 10-14 days after the 13th cycle visit.
The trial will include women who have never used hormonal contraceptives before consent (naïve users), women who have used hormonal contraceptives in the past but have had a contraceptive-free period before consent and a full menstrual cycle during the drug-free period (previous users) as well as women directly switching from another hormonal method (switchers).
Adverse events and safety information will be collected throughout the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LPRI424 | Experimental | Drug: LPRI424 (dienogest/ethinylestradiol)Dienogest 2 mg / ethinyl estradiol 0.02 mg tablet orally once daily for 24 days followed by 4 placebo tablets for a 28 day cycle, for 13 cycles |
Who may qualify
- Ages
- 13 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (20 listed)
- Sexually active, postmenarcheal and premenopausal female subjects at risk of pregnancy aged between 13-45 years (inclusive) (at the time of trial enrollment).
- Female subjects at risk of pregnancy aged between 13 and 17 years (inclusive) provided that:
- Women who:
- Only for subjects who did not use hormonal contraception during the last six months before consent/assent: Regular cycles (i.e. cycle length between 24 and 35 days) during the last six months.
- At least three complete menstrual cycles after delivery pregnancy (only applicable for women who were pregnant within the last six months).
Key exclusion criteria (51 listed)
- Pregnancy, wish for pregnancy, or breastfeeding subjects.
- Subject is known to or suspected of not being able to comply with the trial protocol, the use of the trial medication or the use of the trial diary.
- History of infertility.
- Abnormal finding on pelvic, breast or ultrasound examination that in the investigator's opinion contraindicates participation in the trial.
- Unexplained amenorrhea.
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 |
|---|---|---|
| LPRI424 (dienogest/ethinylestradiol)One LPRI424 tablet once per day for 24 days followed by 4 placebo tablets for 4 days equals one cycle. | Drug | LPRI424 |
Primary outcome
Number of pregnancies (evaluable cycles)
Time frame: up to 13 months
Pearl index (PI) from evaluable cycles in non-breastfeeding women aged ≤ 35 years (at the time of trial enrollment)
7 secondary outcomes
Number of pregnancies (all)
Time frame: up to 13 months
Number of pregnancies (method failures)
Time frame: up to 13 months
Pregnancy ratio
Time frame: up to 13 months
Overall PI, PI for method failures in all women
Time frame: Up to 13 months
Overall PI, PI for method failures in women >35 years
Time frame: Up to 13 months
Number of participants with adverse events as a measure of safety
Time frame: Up to 13 months
Tolerability; Vaginal bleeding pattern
Time frame: Up to 13 months
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 14 Nov 2023.
Related trials for Contraception
RecruitingPhase 4
Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease
Sickle Cell Disease (SCD), Vaso-Occlusive Pain Episode in Sickle Cell Disease
Not yet recruitingObservational study
FLOW: Influence of the Menstrual Cycle on Alcohol Use in Women
Alcohol Use, Alcohol Consumption
Not yet recruiting
Impact of Gender-Transformative Interventions on Contraceptive Use and Reproductive Autonomy in Somalia
Contraceptive Behavior, Social Norms
Recruiting
Impact of Self-Care Family Planning Services on Health and Development in South Sudan (Family Planning Impact Lab)
Contraceptive Behavior, Self Administration
Not yet recruitingPhase 3
Evaluation of the Contraceptive Efficacy and Safety of a New Concentration of an Antiandrogenic Progestogen Combined With a Reduced-Dose Estrogen (LUNA)
Contraception
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.
Enrico Colli, MD study director
Chemo Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LPRI424 (dienogest/ethinylestradiol) in people with Contraception, run by Insud Pharma at 1 site in United States.
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 20 inclusion and 51 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 14 Nov 2023. 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 United States. 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?
Number of pregnancies (evaluable cycles) (time frame: up to 13 months). 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 14 Nov 2023.