ContraceptionPhase 3NCT03154125
Sayana® Press Extension Study
A Phase 3 study testing Sayana® Press in people with Contraception, run by FHI 360 at 3 sites in 3 countries.
Trial summary
This is a randomized clinical trial designed to evaluate the effectiveness, safety and acceptability of Sayana® Press when injected every 4 months (17-18 weeks) for 3 treatment cycles (12 months) of use. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Sayana® Press
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 22 Sep 2017to 18 Nov 2020
- Phase
- Phase 3
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- not pregnant and no desire to become pregnant in the next 18 months
- regular menstrual cycles (25 to 35 days in length when not using hormonal contraception, pregnant, or lactating)
- at risk of pregnancy (no diagnosis of infertility, no history of tubal ligation or hysterectomy, and an average of 1 or more unprotected acts of vaginal intercourse per month)
- in good general health as determined by a medical history
- 18 to 35 years of age, inclusive
- willing to provide informed consent, follow all study requirements, and rely on Sayana® Press injected every 4 months as the only means of contraception for 12 months
- has only one sexual partner and expects to have that same sexual partner for the next 12 months
Who cannot join
- has a primary partner who has received a vasectomy or is otherwise sterile
- medical contraindications to depot medroxyprogesterone acetate (DMPA) per World Health Organization medical eligibility criteria for contraceptive use
- known HIV-infection (for her or her partner)
- diagnosis or treatment for a sexually transmitted infection in the past month (for her or a partner), excluding recurrent herpes or condyloma
- received an injection of a progestin-only containing contraceptive (DMPA or norethisterone enanthate) in the past 12 months
- received an injection of a combined injectable contraceptive in the past 6 months
Show all 13Show fewer
- known or suspected allergic reaction to DMPA
- used a levonorgestrel-releasing intrauterine system, NuvaRing, contraceptive patch, oral contraceptives or a contraceptive implant in the 7 days prior to enrollment (PK cohort only)
- previous (within 1 month prior to enrollment), current or planned (in the next 12 months) use of an investigational drug, prohibited drug per protocol or other drug which in the opinion of the site investigator could complicate study findings
- has been pregnant in the past month
- is lactating
- plans to move to another location in the next 12 months
- has a social or medical condition which in the opinion of the site investigator would make study participation unsafe, or interfere with adherence to protocol requirements.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Dominican Republic1 site
Asociación Dominicana Pro Bienestar de la Familia, Inc. (PROFAMILIA)
Santo Domingo
About this study
Official title: A Study to Evaluate the Effectiveness, Pharmacokinetics, Safety, and Acceptability of Sayana® Press When Injected Every Four Months
This is a randomized clinical trial designed to evaluate the effectiveness, safety and acceptability of Sayana® Press when injected every 4 months (17-18 weeks) for 3 treatment cycles (12 months) of use.
Read the detailed description
This is a randomized, partially-blinded, multi-center, parallel-group study to evaluate the effectiveness, PK, safety, and acceptability of Sayana® Press when injected every 4 months (17-18 weeks) rather than the currently prescribed 3-month (12-14 weeks) regimen.
A total of 750 healthy, sexually active women aged 18 to 35 years with regular menstrual cycles and no DMPA use in the previous 12 months will be enrolled and followed for pregnancy. Among all enrolled, 710 will be randomized to receive injections in the abdomen or upper thigh in accordance with the PATH Sayana® injection instructions, which are consistent with prescribing information, for the primary effectiveness analysis. An additional 40 women will be randomized to receive injections subcutaneously in the back of the upper arm to assess whether differences in PK may exist which could impact the grace period for reinjections for that injection site.
A single MPA serum sample will be collected from all participants at baseline. All participants will receive re-injections at month 4 and month 8, and complete their scheduled follow-up at month 12. There will be a plus 7-day grace period for re-injections, but women who are up to 28 days late may continue treatment if they have a negative urine pregnancy test. Urine pregnancy testing will be performed at month 4, at study exit and at any other time during the study if clinically indicated. Participants will be evaluated for injection site reactions and asked to provide information on adverse events, prohibited concomitant medication and other contraceptive use, vaginal bleeding, and method acceptability at all regular follow-up visits (i.e., not including the PK visits at Months 2 and 3). Serious adverse events and adverse events leading to product withdrawal, will be recorded throughout the study.
- Conditions
- Contraception
- Being tested
- Sayana® Press
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sayana® PressDrug
Also called medroxyprogesterone acetate (MPA) injectable suspension
The active ingredient in Sayana® Press is Medroxyprogesterone acetate (MPA). Sayana® Press (MPA injectable suspension, 104 mg/0.65 mL, pre-filled in the UnijectTM delivery injection system) for subcutaneous injection.
| Study group | Role | What they receive |
|---|---|---|
| Abdomen | Experimental | Sayana® Press (MPA injectable suspension, 104 mg/0.65 mL, pre-filled in the UnijectTM delivery injection system) injected subcutaneously every 4 months (17-18 weeks) for 3 treatment cycles (12 months). Receives: Drug: Sayana® Press |
| Upper thigh | Experimental | Sayana® Press (MPA injectable suspension, 104 mg/0.65 mL, pre-filled in the UnijectTM delivery injection system) injected subcutaneously every 4 months (17-18 weeks) for 3 treatment cycles (12 months). Receives: Drug: Sayana® Press |
| Back of the upper arm | Experimental | Sayana® Press (MPA injectable suspension, 104 mg/0.65 mL, pre-filled in the UnijectTM delivery injection system) injected subcutaneously every 4 months (17-18 weeks) for 3 treatment cycles (12 months). Receives: Drug: Sayana® Press |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Pregnancy
Pregnancy is defined as having a positive urine pregnancy test. Positive urine tests will be confirmed by ultrasound and/or serum hCG testing whenever possible. The primary efficacy analysis will be based on the pregnancy Pearl Index, computed as the number of pregnancies that occur during the treatment period multiplied by 100 and divided by the number of WY of treatment contributed to the Treated Analysis Set among women receiving injections in the abdomen or thigh.
Measured: 12 months after treatment initiation
Secondary outcomes (3)
Serum MPA Concentrations in a Subset of 120 Participants
Pharmacokinetic endpoints include serum MPA concentrations at month 2, 3, 4, 8, and 12.
Measured: 2, 3, 4, 8, and 12 months after treatment initiation
Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal
The overall safety of study drug will be assessed throughout the study by evaluating the occurrence of SAEs and AEs leading to product discontinuation, blood pressure and weight at regularly scheduled visits, and changes in bleeding pattern.
Measured: 12 months after treatment initiation
Acceptability of Sayana® Press
Perception of bleeding patterns and other responses to acceptability questions will be summarized using descriptive statistics based on routine questions asked at regularly scheduled visits (enrollment, months 4 and 8, and final). Acceptability data collected during unscheduled visits are not included in this table.
Measured: 12 months after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study start22 Sep 2017
- Primary completion30 May 2020
- Study completion18 Nov 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.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All participants will receive the same study drug, Sayana® Press. However, women will be randomized to receive their injections in the abdomen, back of the upper arm, or upper thigh to control for potential confounding when assessing relationships between SC injection site, efficacy, and PK. One cohort of N=630 women will be randomized 1:1 to receive their injections in the abdomen or thigh, and a separate PK cohort of N=120 women agreeing to MPA testing will be randomized 1:1:1 to receive their injections in the abdomen, upper thigh, or back of the upper arm. Randomization will be stratified by cohort and site using appropriate randomly permuted block sizes.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- FHI 360
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vera Halpern, MD, Study director, FHI 360
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03154125
- Sponsor's protocol ID
- 926400
- Status last verified
- Aug 2024
- First submitted
- 12 May 2017
- Last updated
- 30 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study sites will collect baseline and longitudinal data among 750 women in Brazil, Chile and the Dominican Republic relevant to the protocol objectives including demographics; sexual, reproductive and medical history; acceptability; serious adverse events; concomitant medication use and laboratory data (including serum blood medroxyprogesterone acetate concentrations in a subset of women). • FHI 360 will submit the study dataset using the platform-independent and non-proprietary comma separated values (also known as \[CSV\]) format. The study dataset will be posted to a third-party data repository, then the link will be submitted to USAID's Data Development Library within 30 calendar days after the dataset is first used to produce an Intellectual Work. A code book defining all variables, a data dictionary describing the relationships among the files within the dataset, and a document describing the methodology used to collect the data will be shared with the study dataset.
Publications
Burke HM, Packer C, Fuchs R, Brache V, Bahamondes L, Salinas A, Veiga N, Miller A, Deese J. Acceptability of the contraceptive Sayana(R) Press when injected every four months: Results from a twelve-month trial in Brazil, Chile and the Dominican Republic. Contraception. 2022 Sep;113:95-100. doi: 10.1016/j.contraception.2022.04.007. Epub 2022 Apr 26.
PubMed 35483431Deese J, Brache V, Bahamondes L, Salinas A, Jorge A, Veiga N Jr, Fuchs R, Miller A, Taylor D, Halpern V, Dorflinger L. Contraceptive effectiveness, pharmacokinetics, and safety of Sayana(R) Press when injected every four months: a multicenter phase 3 trial. EClinicalMedicine. 2022 Jan 29;44:101273. doi: 10.1016/j.eclinm.2022.101273. eCollection 2022 Feb.
PubMed 35128365
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Effectiveness, Pharmacokinetics, Safety, and Acceptability of Sayana® Press When Injected Every Four Months
- ClinicalTrials.gov ID
- NCT03154125
- Acronym / sponsor ID
- 926400
- Conditions
- Contraception
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- FHI 360University, hospital or other
- Study start
- 22 Sep 2017 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 18 Nov 2020 (actual)
- First posted
- 16 May 2017 (actual)
- Results
- Posted 30 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized clinical trial designed to evaluate the effectiveness, safety and acceptability of Sayana® Press when injected every 4 months (17-18 weeks) for 3 treatment cycles (12 months) of use.
Detailed description
This is a randomized, partially-blinded, multi-center, parallel-group study to evaluate the effectiveness, PK, safety, and acceptability of Sayana® Press when injected every 4 months (17-18 weeks) rather than the currently prescribed 3-month (12-14 weeks) regimen.
A total of 750 healthy, sexually active women aged 18 to 35 years with regular menstrual cycles and no DMPA use in the previous 12 months will be enrolled and followed for pregnancy. Among all enrolled, 710 will be randomized to receive injections in the abdomen or upper thigh in accordance with the PATH Sayana® injection instructions, which are consistent with prescribing information, for the primary effectiveness analysis. An additional 40 women will be randomized to receive injections subcutaneously in the back of the upper arm to assess whether differences in PK may exist which could impact the grace period for reinjections for that injection site.
A single MPA serum sample will be collected from all participants at baseline. All participants will receive re-injections at month 4 and month 8, and complete their scheduled follow-up at month 12. There will be a plus 7-day grace period for re-injections, but women who are up to 28 days late may continue treatment if they have a negative urine pregnancy test. Urine pregnancy testing will be performed at month 4, at study exit and at any other time during the study if clinically indicated. Participants will be evaluated for injection site reactions and asked to provide information on adverse events, prohibited concomitant medication and other contraceptive use, vaginal bleeding, and method acceptability at all regular follow-up visits (i.e., not including the PK visits at Months 2 and 3). Serious adverse events and adverse events leading to product withdrawal, will be recorded throughout the study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- All participants will receive the same study drug, Sayana® Press. However, women will be randomized to receive their injections in the abdomen, back of the upper arm, or upper thigh to control for potential confounding when assessing relationships between SC injection site, efficacy, and PK. One cohort of N=630 women will be randomized 1:1 to receive their injections in the abdomen or thigh, and a separate PK cohort of N=120 women agreeing to MPA testing will be randomized 1:1:1 to receive their injections in the abdomen, upper thigh, or back of the upper arm. Randomization will be stratified by cohort and site using appropriate randomly permuted block sizes.
| Arm | Type | Receives |
|---|---|---|
| Abdomen | Experimental | Drug: Sayana® PressSayana® Press (MPA injectable suspension, 104 mg/0.65 mL, pre-filled in the UnijectTM delivery injection system) injected subcutaneously every 4 months (17-18 weeks) for 3 treatment cycles (12 months). |
| Upper thigh | Experimental | Drug: Sayana® PressSayana® Press (MPA injectable suspension, 104 mg/0.65 mL, pre-filled in the UnijectTM delivery injection system) injected subcutaneously every 4 months (17-18 weeks) for 3 treatment cycles (12 months). |
| Back of the upper arm | Experimental | Drug: Sayana® PressSayana® Press (MPA injectable suspension, 104 mg/0.65 mL, pre-filled in the UnijectTM delivery injection system) injected subcutaneously every 4 months (17-18 weeks) for 3 treatment cycles (12 months). |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- not pregnant and no desire to become pregnant in the next 18 months
- regular menstrual cycles (25 to 35 days in length when not using hormonal contraception, pregnant, or lactating)
- at risk of pregnancy (no diagnosis of infertility, no history of tubal ligation or hysterectomy, and an average of 1 or more unprotected acts of vaginal intercourse per month)
- in good general health as determined by a medical history
- 18 to 35 years of age, inclusive
Key exclusion criteria (13 listed)
- has a primary partner who has received a vasectomy or is otherwise sterile
- medical contraindications to depot medroxyprogesterone acetate (DMPA) per World Health Organization medical eligibility criteria for contraceptive use
- known HIV-infection (for her or her partner)
- diagnosis or treatment for a sexually transmitted infection in the past month (for her or a partner), excluding recurrent herpes or condyloma
- received an injection of a progestin-only containing contraceptive (DMPA or norethisterone enanthate) in the past 12 months
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 |
|---|---|---|
| Sayana® PressAlso: medroxyprogesterone acetate (MPA) injectable suspensionThe active ingredient in Sayana® Press is Medroxyprogesterone acetate (MPA). Sayana® Press (MPA injectable suspension, 104 mg/0.65 mL, pre-filled in the UnijectTM delivery injection system) for subcutaneous injection. | Drug | Abdomen, Back of the upper arm, Upper thigh |
Primary outcome
Occurrence of Pregnancy
Time frame: 12 months after treatment initiation
Pregnancy is defined as having a positive urine pregnancy test. Positive urine tests will be confirmed by ultrasound and/or serum hCG testing whenever possible. The primary efficacy analysis will be based on the pregnancy Pearl Index, computed as the number of pregnancies that occur during the treatment period multiplied by 100 and divided by the number of WY of treatment contributed to the Treated Analysis Set among women receiving injections in the abdomen or thigh.
3 secondary outcomes
Serum MPA Concentrations in a Subset of 120 Participants
Time frame: 2, 3, 4, 8, and 12 months after treatment initiation
Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal
Time frame: 12 months after treatment initiation
Acceptability of Sayana® Press
Time frame: 12 months after treatment initiation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35483431Burke HM, Packer C, Fuchs R, Brache V, Bahamondes L, Salinas A, Veiga N, Miller A, Deese J. Acceptability of the contraceptive Sayana(R) Press when injected every four months: Results from a twelve-month trial in Brazil, Chile and the Dominican Republic. Contraception. 2022 Sep;113:95-100. doi: 10.1016/j.contraception.2022.04.007. Epub 2022 Apr 26.
- Derived from this study: PubMed 35128365Deese J, Brache V, Bahamondes L, Salinas A, Jorge A, Veiga N Jr, Fuchs R, Miller A, Taylor D, Halpern V, Dorflinger L. Contraceptive effectiveness, pharmacokinetics, and safety of Sayana(R) Press when injected every four months: a multicenter phase 3 trial. EClinicalMedicine. 2022 Jan 29;44:101273. doi: 10.1016/j.eclinm.2022.101273. eCollection 2022 Feb.
- Individual participant dataSharing planned: Yes. Study sites will collect baseline and longitudinal data among 750 women in Brazil, Chile and the Dominican Republic relevant to the protocol objectives including demographics; sexual, reproductive and medical history; acceptability; serious adverse events; concomitant medication use and laboratory data (including serum blood medroxyprogesterone acetate concentrations in a subset of women). • FHI 360 will submit the study dataset using the platform-independent and non-proprietary comma separated values (also known as [CSV]) format. The study dataset will be posted to a third-party data repository, then the link will be submitted to USAID's Data Development Library within 30 calendar days after the dataset is first used to produce an Intellectual Work. A code book defining all variables, a data dictionary describing the relationships among the files within the dataset, and a document describing the methodology used to collect the data will be shared with the study dataset.
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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.
Vera Halpern, MD study director
FHI 360
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sayana® Press in people with Contraception, run by FHI 360 at 3 sites in 3 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 7 inclusion and 13 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 30 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Brazil, Chile, 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. 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?
Yes. Results are posted in the registry (first posted 30 Aug 2024). 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?
Occurrence of Pregnancy (time frame: 12 months after treatment initiation). 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 NCT03154125, which also lists 2 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 30 Aug 2024.