Birth ControlPhase 4NCT04676061
Effects of a Progestin on Frequent and/or Prolonged Bleeding With Nexplanon™
A Phase 4 study testing Norethindrone acetate (NTA) in people with Birth Control and Contraception, run by Baylor Research Institute at 1 site in United States.
Trial summary
Effects of norethindrone acetate (NTA) in patients with Nexplanon. Read more about this study
- Who is it for?
- Ages 14 to 48 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Birth Control, Contraception, Implant
- What is being tested?
- Norethindrone acetate (NTA)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2021to 10 Mar 2023
- Phase
- Phase 4
- 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 14 to 48 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Between the ages of 18-48
- Between ages of 14-17 with parental/guardian permission
- Women desiring placement of Nexplanon™
- Willing to keep a daily symptom calendar
- Keep appointments
- Women not desiring to become pregnant in the next 2 years
Who cannot join
- Known or suspected Pregnancy
- Less than 8weeks postpartum
- Menarche less than two years ago
- Current or past history of thrombosis or thromboembolic disorders
- Hepatic tumors (benign or malignant)
- Active liver disease
Show all 12Show fewer
- Undiagnosed abnormal genital bleeding
- Undiagnosed headaches
- Known or suspected carcinoma of the breast or personal history of breast cancer
- Hypersensitivity to any of the components in Nexplanon™
- BMI greater than 40
- Depomedroxyprogesterone acetate injection in the previous 12 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Progestin on Frequent and/or Prolonged Bleeding With Nexplanon™; a Randomized Double-Blinded Placebo-Controlled Trial
Effects of norethindrone acetate (NTA) in patients with Nexplanon.
Read the detailed description
The purpose of this study is to find out what effects norethindrone acetate (NTA) has on the duration and recurrence of frequent and/or prolonged bleeding associated with Nexplanon™.
- Conditions
- Birth Control, Contraception, Implant, Breakthrough Bleeding, Uterine Bleeding
- Being tested
- Norethindrone acetate (NTA), Placebo
- Keywords
- Uterine Hemorrhage, Norethindrone Acetate, Contraceptives
- Medical subject headings
- Metrorrhagia, Uterine Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Norethindrone acetate (NTA)Drug
norethindrone acetate, 5 mg tablet, orally, once daily for 7 consecutive days, every 4 weeks
PlaceboDrug
Placebo, tablet, orally, once daily for 7 consecutive days, every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | Placebo to Norethindrone acetate (NTA) Receives: Drug: Placebo |
| Treatment Group | Active comparator | Norethindrone acetate (NTA) Receives: Drug: Norethindrone acetate (NTA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days of bleeding and spotting
To evaluate days of bleeding and spotting within 90-day intervals by quantifying a self-perception of amount of bleeding on a scale of 0 to 4 and associated symptoms on a scale of 0 to 10 using the Daily Dairy of Symptoms
Measured: 30 days
Secondary outcomes (1)
Quality of life measurements
To evaluate quality of life by comparing the treatment and placebo groups' associated symptoms on a scale of 0 to 10 using the Daily Diary of Symptoms.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start11 Feb 2021
- Primary completion18 Jul 2022
- Study completion10 Mar 2023
Why it stopped: It was in the best interest of the investigator to terminate the study earlier than anticipated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Birth ControlStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Joanna Stacey, MD, Principal investigator, Baylor Reserach Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04676061
- Sponsor's protocol ID
- 020-291
- Status last verified
- Mar 2023
- First submitted
- 11 Dec 2020
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Progestin on Frequent and/or Prolonged Bleeding With Nexplanon™; a Randomized Double-Blinded Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT04676061
- Acronym / sponsor ID
- 020-291
- Conditions
- Birth Control, Contraception, Implant, Breakthrough Bleeding, Uterine Bleeding
- Keywords
- Uterine Hemorrhage, Norethindrone Acetate, Contraceptives
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: It was in the best interest of the investigator to terminate the study earlier than anticipated.
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 11 Feb 2021 (actual)
- Primary completion
- 18 Jul 2022 (actual)
- Study completion
- 10 Mar 2023 (actual)
- First posted
- 19 Dec 2020 (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.
Effects of norethindrone acetate (NTA) in patients with Nexplanon.
Detailed description
The purpose of this study is to find out what effects norethindrone acetate (NTA) has on the duration and recurrence of frequent and/or prolonged bleeding associated with Nexplanon™.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Drug: PlaceboPlacebo to Norethindrone acetate (NTA) |
| Treatment Group | Active comparator | Drug: Norethindrone acetate (NTA)Norethindrone acetate (NTA) |
Who may qualify
- Ages
- 14 to 48 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Between the ages of 18-48
- Between ages of 14-17 with parental/guardian permission
- Women desiring placement of Nexplanon™
- Willing to keep a daily symptom calendar
- Keep appointments
Key exclusion criteria (12 listed)
- Known or suspected Pregnancy
- Less than 8weeks postpartum
- Menarche less than two years ago
- Current or past history of thrombosis or thromboembolic disorders
- Hepatic tumors (benign or malignant)
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 |
|---|---|---|
| Norethindrone acetate (NTA)norethindrone acetate, 5 mg tablet, orally, once daily for 7 consecutive days, every 4 weeks | Drug | Treatment Group |
| PlaceboPlacebo, tablet, orally, once daily for 7 consecutive days, every 4 weeks | Drug | Control Group |
Primary outcome
Number of days of bleeding and spotting
Time frame: 30 days
To evaluate days of bleeding and spotting within 90-day intervals by quantifying a self-perception of amount of bleeding on a scale of 0 to 4 and associated symptoms on a scale of 0 to 10 using the Daily Dairy of Symptoms
1 secondary outcome
Quality of life measurements
Time frame: 30 days
Results and safety
The study was stopped early (reason given: It was in the best interest of the investigator to terminate the study earlier than anticipated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 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.
Joanna Stacey, MD principal investigator
Baylor Reserach Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Norethindrone acetate (NTA) in people with Birth Control and Contraception, run by Baylor Research Institute 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 6 inclusion and 12 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: stopped early, as of the sponsor's last update on 2 Feb 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 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early (reason given: It was in the best interest of the investigator to terminate the study earlier than anticipated.). Results are not available in the source record.
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 days of bleeding and spotting (time frame: 30 days). 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 2 Feb 2024.