ContraceptionPhase 1NCT02732418
Lower Dose Depo Provera® Contraceptive Injection
A Phase 1 study testing Depo-Provera CI and Depo-subQ 104 in people with Contraception, run by FHI 360 at 3 sites in 3 countries.
Trial summary
This is a randomized, partially-blinded, multi-center, parallel-group study to evaluate and compare the PD and PK of MPA after a single SC injection of either 45 mg/0.3 mL, 75 mg/0.5 mL or 105 mg/0.7 mL of Depo-Provera CI, and one cycle of Depo-subQ 104 use when injected in the abdomen, in women of reproductive age… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Depo-Provera CI and Depo-subQ 104
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 2 Dec 2016to 15 May 2018
- Phase
- Phase 1
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- has typical menstrual cycle of 24 to 35 days
- has confirmed ovulatory cycle during the pretreatment phase (serum progesterone ≥ 4.7 ng/mL in 2 consecutive samples)
- is sterilized or using non hormonal intrauterine device (IUD)
- is in good general health as determined by a medical history and physical examination
- 18 to 40 years of age (inclusive)
- willing to provide informed consent and follow all study requirements
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- has negative urine pregnancy test and has no desire to become pregnant in the subsequent 12 months
- has a body mass index (BMI) of 18.0 to 35.0 kg/m2, inclusive
- has hemoglobin ≥10.5 g/dL
Who cannot join
- has medical contraindications to depot medroxyprogesterone acetate (DMPA) [16]
- has undiagnosed mass in breast
- used DMPA in the past 12 months
- used a combined injectable contraceptive in the past 6 months
- used any of the following medications within 1 month prior to enrollment:
- any investigational drug
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- prohibited drugs per protocol
- oral contraceptives
- Nuva-ring
- contraceptive patch
- levonorgestrel intrauterine system (LNG IUS) or contraceptive implant
- has been pregnant within last 3 months
- Is currently lactating
- in the opinion of the investigator, is potentially at elevated risk of HIV infection (HIV-positive partner, IV drug use by self or by partner)
- has more than one male sexual partner
- is using or plans to use prohibited drugs per protocol in the next 9 months
- has known sensitivity to MPA
- plans to move to another location in the next 9 months
- has any condition (social or medical), which in the opinion of the investigator would make study participation unsafe, would interfere with adherence to the clinical study requirements or complicate data interpretation
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 Suppression of Ovulation Following a Single Subcutaneous Administration of Various Doses of Depo-Provera CI
This is a randomized, partially-blinded, multi-center, parallel-group study to evaluate and compare the PD and PK of MPA after a single SC injection of either 45 mg/0.3 mL, 75 mg/0.5 mL or 105 mg/0.7 mL of Depo-Provera CI, and one cycle of Depo-subQ 104 use when injected in the abdomen, in women of reproductive age with confirmed ovulatory baseline cycle
Read the detailed description
This is a randomized, partially-blinded, multi-center, parallel-group study to evaluate and compare the PD and PK of MPA after a single SC injection of either 45 mg/0.3 mL, 75 mg/0.5 mL or 105 mg/0.7 mL of Depo-Provera CI, and one cycle of Depo-subQ 104 use when injected in the abdomen, in women of reproductive age with confirmed ovulatory baseline cycle. Baseline ovulation will be confirmed in all women by measuring serum progesterone (P) approximately twice a week during the 2-3 weeks preceding expected menses. Between 48 and 60 participants (12-15 per group) with confirmed ovulation who meet other eligibility criteria will be enrolled and randomized to receive a single SC injection in the abdomen of 1 of 3 doses of Depo-Provera CI: 45 mg/0.3 mL, 75 mg/0.5 mL or 105 mg/0.7 mL or a single dose of Depo-subQ Provera (104 mg/0.65mL). Participants will be followed for 32 weeks (7.5 months) after the injection During the study participants will provide blood samples for MPA, P and estradiol (E2) prior to injection and then frequently at predefined time points through 7.5 months. In addition, for more accurate ascertainment of the PD response we will perform transvaginal ultrasound (TVS) and assess cervical mucus at predefined time points through 7.5 months. Information on adverse events and concomitant medications will be collected throughout the study. Information on acceptability will be collected at predefined time points through 7.5 months.
- Conditions
- Contraception
- Being tested
- Depo-Provera CI, Depo-subQ 104
- Keywords
- CI-contraceptive injection, DMPA-Depot medroxyprogesterone acetate, MPA-Medroxyprogesterone Acetate, subQ-subcutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Depo-Provera CIDrug
Also called Depo Provera® Contraceptive Injection
The active ingredient in Depo-Provera is Medroxyprogesterone acetate (MPA)
Depo-subQ 104Drug
Also called depo-subQ provera 104®
The active ingredient in Depo-Provera is Medroxyprogesterone acetate (MPA). Depo-subQ provera 104® (medroxyprogesterone acetate injectable suspension, 104 mg/0.65mL) for subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Depo-Provera CI 45 mg | Experimental | a single subcutaneous (SC) injection of 45 mg/0.3 mL Receives: Drug: Depo-Provera CI |
| Depo-Provera CI 75 mg | Experimental | a single subcutaneous (SC) injection of 75 mg/0.5 mL Receives: Drug: Depo-Provera CI |
| Depo-Provera CI 105 mg | Experimental | a single subcutaneous (SC) injection of 105 mg/0.7 mL Receives: Drug: Depo-Provera CI |
| Depo-subQ 104 | Active comparator | a single subcutaneous (SC) injection of 104 mg/0.65 mL Receives: Drug: Depo-subQ 104 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to ovulation
Time to ovulation indicated by time to reach rupture of the lead follicle based on transvaginal ultrasound (TVS) findings followed by serum progesterone level of >=4.7 ng/mL. The primary objective will be assessed by estimating the cumulative probability of return to ovulation through Month 7.5 from start of therapy in each test group based on the Kaplan-Meier product-limit method, with 95% confidence intervals derived using the complementary log-log transformation.
Measured: 32 weeks after receiving drug
Secondary outcomes (3)
Measurement of serum MPA concentrations
Measure of Peak Concentrations (Cmax)
Measured: 32 weeks after receiving drug
Time to maximum serum concentration of MPA
Time to reach peak concentration of MPA(Tmax)
Measured: 32 weeks after receiving drug
Occurrence of adverse events
Measured: 32 weeks after receiving drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2016 (estimated)
- Study start2 Dec 2016
- Primary completion15 May 2018
- Study completion15 May 2018
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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- FHI 360
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vera Halpern, MD, Principal investigator, FHI 360
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02732418
- Sponsor's protocol ID
- 834119
- Status last verified
- Jun 2018
- First submitted
- 30 Mar 2016
- Last updated
- 14 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate Suppression of Ovulation Following a Single Subcutaneous Administration of Various Doses of Depo-Provera CI
- ClinicalTrials.gov ID
- NCT02732418
- Acronym / sponsor ID
- 834119
- Conditions
- Contraception
- Keywords
- CI-contraceptive injection, DMPA-Depot medroxyprogesterone acetate, MPA-Medroxyprogesterone Acetate, subQ-subcutaneous
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- FHI 360University, hospital or other
- Study start
- 2 Dec 2016 (actual)
- Primary completion
- 15 May 2018 (actual)
- Study completion
- 15 May 2018 (actual)
- First posted
- 8 Apr 2016 (estimated)
- 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.
This is a randomized, partially-blinded, multi-center, parallel-group study to evaluate and compare the PD and PK of MPA after a single SC injection of either 45 mg/0.3 mL, 75 mg/0.5 mL or 105 mg/0.7 mL of Depo-Provera CI, and one cycle of Depo-subQ 104 use when injected in the abdomen, in women of reproductive age with confirmed ovulatory baseline cycle
Detailed description
This is a randomized, partially-blinded, multi-center, parallel-group study to evaluate and compare the PD and PK of MPA after a single SC injection of either 45 mg/0.3 mL, 75 mg/0.5 mL or 105 mg/0.7 mL of Depo-Provera CI, and one cycle of Depo-subQ 104 use when injected in the abdomen, in women of reproductive age with confirmed ovulatory baseline cycle. Baseline ovulation will be confirmed in all women by measuring serum progesterone (P) approximately twice a week during the 2-3 weeks preceding expected menses. Between 48 and 60 participants (12-15 per group) with confirmed ovulation who meet other eligibility criteria will be enrolled and randomized to receive a single SC injection in the abdomen of 1 of 3 doses of Depo-Provera CI: 45 mg/0.3 mL, 75 mg/0.5 mL or 105 mg/0.7 mL or a single dose of Depo-subQ Provera (104 mg/0.65mL). Participants will be followed for 32 weeks (7.5 months) after the injection During the study participants will provide blood samples for MPA, P and estradiol (E2) prior to injection and then frequently at predefined time points through 7.5 months. In addition, for more accurate ascertainment of the PD response we will perform transvaginal ultrasound (TVS) and assess cervical mucus at predefined time points through 7.5 months. Information on adverse events and concomitant medications will be collected throughout the study. Information on acceptability will be collected at predefined time points through 7.5 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Depo-Provera CI 45 mg | Experimental | Drug: Depo-Provera CIa single subcutaneous (SC) injection of 45 mg/0.3 mL |
| Depo-Provera CI 75 mg | Experimental | Drug: Depo-Provera CIa single subcutaneous (SC) injection of 75 mg/0.5 mL |
| Depo-Provera CI 105 mg | Experimental | Drug: Depo-Provera CIa single subcutaneous (SC) injection of 105 mg/0.7 mL |
| Depo-subQ 104 | Active comparator | Drug: Depo-subQ 104a single subcutaneous (SC) injection of 104 mg/0.65 mL |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- has typical menstrual cycle of 24 to 35 days
- has confirmed ovulatory cycle during the pretreatment phase (serum progesterone ≥ 4.7 ng/mL in 2 consecutive samples)
- is sterilized or using non hormonal intrauterine device (IUD)
- is in good general health as determined by a medical history and physical examination
- 18 to 40 years of age (inclusive)
Key exclusion criteria (19 listed)
- has medical contraindications to depot medroxyprogesterone acetate (DMPA) [16]
- has undiagnosed mass in breast
- used DMPA in the past 12 months
- used a combined injectable contraceptive in the past 6 months
- used any of the following medications within 1 month prior to enrollment:
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 |
|---|---|---|
| Depo-Provera CIAlso: Depo Provera® Contraceptive InjectionThe active ingredient in Depo-Provera is Medroxyprogesterone acetate (MPA) | Drug | Depo-Provera CI 105 mg, Depo-Provera CI 45 mg, Depo-Provera CI 75 mg |
| Depo-subQ 104Also: depo-subQ provera 104®The active ingredient in Depo-Provera is Medroxyprogesterone acetate (MPA). Depo-subQ provera 104® (medroxyprogesterone acetate injectable suspension, 104 mg/0.65mL) for subcutaneous injection | Drug | Depo-subQ 104 |
Primary outcome
Time to ovulation
Time frame: 32 weeks after receiving drug
Time to ovulation indicated by time to reach rupture of the lead follicle based on transvaginal ultrasound (TVS) findings followed by serum progesterone level of >=4.7 ng/mL. The primary objective will be assessed by estimating the cumulative probability of return to ovulation through Month 7.5 from start of therapy in each test group based on the Kaplan-Meier product-limit method, with 95% confidence intervals derived using the complementary log-log transformation.
3 secondary outcomes
Measurement of serum MPA concentrations
Time frame: 32 weeks after receiving drug
Time to maximum serum concentration of MPA
Time frame: 32 weeks after receiving drug
Occurrence of adverse events
Time frame: 32 weeks after receiving drug
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 Jun 2018.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data
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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 principal investigator
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 1 study testing Depo-Provera CI and Depo-subQ 104 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 9 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 14 Jun 2018. 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 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?
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?
Time to ovulation (time frame: 32 weeks after receiving drug). 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 Jun 2018.