ContraceptionPhase 1NCT03700658
A Study to Evaluate Injection Pain and Local Tolerability Following Subcutaneous (SC) Administration of TV-46046
A Phase 1 study testing TV-46046 and Depo-subQ 104 in people with Contraception, run by Teva Branded Pharmaceutical Products R&D, Inc. at 1 site in Dominican Republic.
Trial summary
The purpose of this study is to evaluate the local tolerability associated with the SC administration of TV-46046, and inform next steps of the TV-46046 development program. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- TV-46046 and Depo-subQ 104
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteDominican Republic
- Study dates
- 15 Jan 2019to 2 Oct 2020
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant has a low risk of pregnancy (that is, sterilized, in exclusively same-sex partnership, in menopause and/or post-menopausal, abstinent, in a monogamous relationship with vasectomized partner, using nonhormonal intrauterine device [IUD], or consistent use of condoms)
- Participant is not pregnant and does not have desire to become pregnant in the subsequent 18 months
- Participant had a normal mammogram within the last year, if 40 years or older
- Participant has no skin disorders or skin allergies
- Additional criteria apply, please contact the investigator for more information
Who cannot join
- Participant has hypertension
- Participant has ischemic heart disease or a history of ischemic heart disease
- Participant has a history of stroke
- Participant has a history of thromboembolic event(s)
- Participant has systemic lupus erythematosus
- Participant has rheumatoid arthritis and is undergoing immunosuppressive therapy
Show all 19Show fewer
- Participant has migraine with aura
- Participant has unexplained vaginal bleeding
- Participant has diabetes
- Participant has a strong family history of breast cancer
- Participant has cervical cancer or a history of cervical cancer
- Participant has severe cirrhosis (decompensated) or liver tumors
- Participant has known significant renal disease
- Participant has a history of diagnosed clinical depression or bipolar disorder, with or without suicidal ideation, and/or history of suicide attempt
- Participant is currently using hormonal contraception
- Participant had an injection of DMPA (Depo-Provera CI or Depo-subQ 104) in the past 12 months; or combined injectable in the last 3 months
- Participant is chronically using pain medication
- Participant has a plan to move to another location in the next 18 months
- Additional criteria apply, please contact the investigator for more information
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Cross-Over Study to Evaluate Local Tolerability Following Subcutaneous Administration of TV-46046
The purpose of this study is to evaluate the local tolerability associated with the SC administration of TV-46046, and inform next steps of the TV-46046 development program.
Read the detailed description
Eligible participants will be enrolled and receive 1 of each of the 4 SC study injections in each abdominal quadrant approximately 1 hour apart: 120 milligrams (mg)/0.3 milliliter (mL) of TV-46046, 60 mg/0.3 mL of 1:1 saline diluted TV-46046, 0.3 mL of TV-46046 Placebo and 104 mg/0.65 mL Depo-subQ 104 per the assigned sequence.
- Conditions
- Contraception
- Being tested
- TV-46046, Depo-subQ 104, TV-46046 Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TV-46046Drug
TV-46046 will be administered per dose and schedule specified in the arm.
Depo-subQ 104Drug
Also called Medroxyprogesterone acetate injectable suspension, Depo-subQ Provera 104®
Depo-subQ 104 will be administered per dose and schedule specified in the arm.
TV-46046 PlaceboDrug
TV-46046 Placebo will be administered per schedule specified in the arm.
| Study group | Role | What they receive |
|---|---|---|
| TV-46046 Undiluted | Experimental | Participants will receive TV-46046 undiluted (120 mg/0.3 mL of 400 mg/mL) SC injection as a test formulation in a crossover design with the other 3 SC study drug injections. The 4 study drug injections will be administered approximately 1 hour apart. Receives: Drug: TV-46046 |
| TV-46046 Diluted | Experimental | Participants will receive TV-46046 saline-diluted (60 mg/0.3 mL of 200 mg/mL) SC injection as a test formulation in a crossover design with the other 3 SC study drug injections. The 4 study drug injections will be administered approximately 1 hour apart. Receives: Drug: TV-46046 |
| TV-46046 Placebo | Placebo comparator | Participants will receive TV-46046 placebo (0.3 mL) SC injection in a crossover design with the other 3 SC study drug injections. The 4 study drug injections will be administered approximately 1 hour apart. Receives: Drug: TV-46046 Placebo |
| Depo-subQ 104 | Active comparator | Participants will receive Depo-subQ 104 (medroxyprogesterone acetate injectable suspension; 104 mg/0.65 mL) SC injection as a reference formulation in a crossover design with the other 3 SC study drug injections. The 4 study drug injections will be administered approximately 1 hour apart. Receives: Drug: Depo-subQ 104 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Injection Site Reactions (ISRs) (Excluding Injection Site Pain)
ISRs were assessed by self-reports and direct observation for each injection at least twice on the day of injection. ISRs included erythema (redness), swelling, pruritus (itching), bleeding, bruising, injection site discoloration (for example, hypopigmentation), or atrophy (that is, dimple).
Measured: Day 0 (immediately after and 1 hour after the injection) up to Month 18
Secondary outcomes (3)
Injection Site Pain Score, as Assessed by Numerical Rating Scale (NRS)
Participants assessed their injection site pain using an 11-point NRS (0 = no pain at all; 10 = worst pain). Higher scores denote worse outcome.
Measured: Day 0 (Immediately after and 1 hour after injection)
Participant's Perception of Pain, as Assessed by an Overall Ranking of the 4 Study Injections From Least to Most Painful
Each participant was asked to rank the injections according to overall pain from least (score = 1) to most (score = 4) painful. If a participant could not rank all of her injections from least to most painful or could not uniquely identify which injection was the most painful, then her responses were appropriately weighted across groups (for example, if a participant ranked all 4 treatments as equally most painful, then that participant contributed a score of 0.25 to each group when assessing the distribution of the most painful injection and in the event of a tie between 2 rankings, 0.5 was assigned to each tied ranking).
Measured: Day 0 (1 hour after injection)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs were considered treatment emergent if (a) the onset occurred on or after the time of first injection or (b) an event had an onset prior to the first injection but increased in severity after administration of the injection. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Measured: Day 0 up to Month 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start15 Jan 2019
- Primary completion2 Oct 2020
- Study completion2 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- FHI 360
- Responsible party
- Sponsor
- Investigators
- Teva Medical Expert, MD, Study director, Teva Branded Pharmaceutical Products R&D, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03700658
- Sponsor's protocol ID
- TV46046-WH-10147
- Status last verified
- Nov 2021
- First submitted
- 3 Oct 2018
- Last updated
- 26 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Cross-Over Study to Evaluate Local Tolerability Following Subcutaneous Administration of TV-46046
- ClinicalTrials.gov ID
- NCT03700658
- Acronym / sponsor ID
- TV46046-WH-10147
- Conditions
- Contraception
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Collaborators
- FHI 360
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 2 Oct 2020 (actual)
- Study completion
- 2 Oct 2020 (actual)
- First posted
- 9 Oct 2018 (actual)
- Results
- Posted 26 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the local tolerability associated with the SC administration of TV-46046, and inform next steps of the TV-46046 development program.
Detailed description
Eligible participants will be enrolled and receive 1 of each of the 4 SC study injections in each abdominal quadrant approximately 1 hour apart: 120 milligrams (mg)/0.3 milliliter (mL) of TV-46046, 60 mg/0.3 mL of 1:1 saline diluted TV-46046, 0.3 mL of TV-46046 Placebo and 104 mg/0.65 mL Depo-subQ 104 per the assigned sequence.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TV-46046 Undiluted | Experimental | Drug: TV-46046Participants will receive TV-46046 undiluted (120 mg/0.3 mL of 400 mg/mL) SC injection as a test formulation in a crossover design with the other 3 SC study drug injections. The 4 study drug injections will be administered approximately 1 hour apart. |
| TV-46046 Diluted | Experimental | Drug: TV-46046Participants will receive TV-46046 saline-diluted (60 mg/0.3 mL of 200 mg/mL) SC injection as a test formulation in a crossover design with the other 3 SC study drug injections. The 4 study drug injections will be administered approximately 1 hour apart. |
| TV-46046 Placebo | Placebo comparator | Drug: TV-46046 PlaceboParticipants will receive TV-46046 placebo (0.3 mL) SC injection in a crossover design with the other 3 SC study drug injections. The 4 study drug injections will be administered approximately 1 hour apart. |
| Depo-subQ 104 | Active comparator | Drug: Depo-subQ 104Participants will receive Depo-subQ 104 (medroxyprogesterone acetate injectable suspension; 104 mg/0.65 mL) SC injection as a reference formulation in a crossover design with the other 3 SC study drug injections. The 4 study drug injections will be administered approximately 1 hour apart. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Participant has a low risk of pregnancy (that is, sterilized, in exclusively same-sex partnership, in menopause and/or post-menopausal, abstinent, in a monogamous relationship with vasectomized partner, using nonhormonal intrauterine device [IUD], or consistent use of condoms)
- Participant is not pregnant and does not have desire to become pregnant in the subsequent 18 months
- Participant had a normal mammogram within the last year, if 40 years or older
- Participant has no skin disorders or skin allergies
Key exclusion criteria (19 listed)
- Participant has hypertension
- Participant has ischemic heart disease or a history of ischemic heart disease
- Participant has a history of stroke
- Participant has a history of thromboembolic event(s)
- Participant has systemic lupus erythematosus
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 |
|---|---|---|
| TV-46046TV-46046 will be administered per dose and schedule specified in the arm. | Drug | TV-46046 Diluted, TV-46046 Undiluted |
| Depo-subQ 104Also: Medroxyprogesterone acetate injectable suspension, Depo-subQ Provera 104®Depo-subQ 104 will be administered per dose and schedule specified in the arm. | Drug | Depo-subQ 104 |
| TV-46046 PlaceboTV-46046 Placebo will be administered per schedule specified in the arm. | Drug | TV-46046 Placebo |
Primary outcome
Number of Participants With Injection Site Reactions (ISRs) (Excluding Injection Site Pain)
Time frame: Day 0 (immediately after and 1 hour after the injection) up to Month 18
ISRs were assessed by self-reports and direct observation for each injection at least twice on the day of injection. ISRs included erythema (redness), swelling, pruritus (itching), bleeding, bruising, injection site discoloration (for example, hypopigmentation), or atrophy (that is, dimple).
3 secondary outcomes
Injection Site Pain Score, as Assessed by Numerical Rating Scale (NRS)
Time frame: Day 0 (Immediately after and 1 hour after injection)
Participant's Perception of Pain, as Assessed by an Overall Ranking of the 4 Study Injections From Least to Most Painful
Time frame: Day 0 (1 hour after injection)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: Day 0 up to Month 18
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.
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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.
Teva Medical Expert, MD study director
Teva Branded Pharmaceutical Products R&D, Inc.
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 TV-46046 and Depo-subQ 104 in people with Contraception, run by Teva Branded Pharmaceutical Products R&D, Inc. at 1 site in Dominican Republic.
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 5 inclusion and 19 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 26 Jan 2022. 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 Dominican Republic. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 26 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Participants With Injection Site Reactions (ISRs) (Excluding Injection Site Pain) (time frame: Day 0 (immediately after and 1 hour after the injection) up to Month 18). 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 26 Jan 2022.