ClinicalTrials.gg
CompletedNCT03282799Updated Sep 5, 2024Results posted

Pharmacologic Strategies for the Etonogestrel Implant in HIV-Infected Women

A Phase 2 interventional study of etonogestrel implant in HIV/AIDS and Contraception, sponsored by Catherine Anne Chappell. Completed at 1 site in Uganda. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2024-09-05.

Sponsored by Catherine Anne Chappell · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 120 studies in Acquired Immunodeficiency Syndrome with a site in Uganda — 16 open to participants now, 23 under way, 5 of them phase 3. Acquired Immunodeficiency Syndrome · Uganda.

Enrollment
83rd of 102
72 · median 387
Started
2019
with 7 others
Phase 2
8 of 120
none open now
Registered
57th of 120
by date

Among the 120 studies in Acquired Immunodeficiency Syndrome with a site in Uganda, this one is the 83rd largest by enrollment of the 102 interventional ones, is one of 8 that started in 2019, is one of 8 in phase 2, and was the 57th registered.

By phase

120 studies; the count open now beside each. This study's row is marked.

No phase54 · 11 open
Observational18 · 0 open
Phase 316 · 2 open
Phase 411 · 1 open
Phase 2this study8 · 0 open
Phase 2/36 · 1 open
Phase 14 · 1 open
Phase 1/23 · 0 open

By the year they started

First in 2004; this study’s year is marked. 8 started in 2019.

Size and results

Median enrollment 387 across the 102 interventional studies, 350 across the 18 observational. Of the 86 that completed or were terminated, 34 (40%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 120 studies in Acquired Immunodeficiency Syndrome with a site in Uganda, or all of them as a file.
02

Study summary

This study will evaluate the frequency of ovulation and cervical mucus quality of HIV-infected Ugandan women on efavirenz-based antiretroviral therapy using either a single etonogestrel implant or two etonogestrel implants for at least one year.

Read the detailed description

This study is being done to compare the rate of ovulation when women receive two subdermal implant contraception devices containing the hormone etonogestrel (instead of only one device) while taking the HIV drug efavirenz. The etonogestrel implant is a device that is inserted under the skin on the upper arm and releases a small amount of drug into the body every day over a long period of time to prevent pregnancy for 3 years. A total of 72 non-pregnant women in Uganda, who agree to use the copper intrauterine device throughout the study, will participate in this study. Half will be assigned by chance to use one implant and half will be assigned to use two implants at the entry visit. After the entry visit to place the implant, visits will be scheduled 1 week, 4 weeks, 9 weeks, 10 weeks, 11 weeks, 12 weeks, 21 weeks, 22, weeks, 23 weeks, 24 weeks, 36 weeks, 45 weeks, 46 weeks, 47 weeks, and 48 weeks after the implant(s) were placed. The rate of ovulation (determined by weekly endogenous progesterone concentrations in the blood during months 3, 6, and 12) will be compared between women that receive two 68 mg etonogestrel implants compared to one 68 mg etonogestrel implant in combination with efavirenz-based antiretroviral therapy. Cervical mucus quality (from cervical mucus samples collected weekly at months 3, 6, and 12), the blood concentration of etonogestrel (from blood samples collected at day 3 and weeks 1, 4, 12, 24, 36, 48) and efavirenz (from blood samples collected at enrollment and weeks 4, 12, 24, 36, 48, and the number of adverse events deemed related to etonogestrel implant use through 48 weeks will also be compared between the one- and two-implant study arms.

03

Conditions studied

  • HIV/AIDS
  • Contraception

Keywords

  • etonogestrel
  • efavirenz
  • antiretroviral therapy
  • HIV
04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Evidence of a personally signed and dated document indicating that the participant has been informed of all pertinent aspects of the study.
  2. Participants who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
  3. Women aged 18 years to 40 years.
  4. Diagnosed with infection.
  5. Medically eligible for the etonogestrel subdermal implant as a method.
  6. Receiving efavirenz-based anti-retroviral therapy for a minimum of 3 months prior to screening.
  7. Must agree to have concurrent highly effective non-hormonal contraception with a copper intrauterine device, if not previously medically sterilized.
  8. Participants must report regular menses (bleeding for 4-8 days at 21- to 35-day intervals) for the preceding 2 months.
  9. Participants must have a negative urine pregnancy test at entry and report no unprotected sex since the last menstrual period or in the last two weeks.

Exclusion criteria

Exclusion Criteria:

  1. RNA > 50 copies/mL at screening visit.
  2. Serum \< 10.0 g/dL.
  3. Elevations in serum levels of above 5 times the .
  4. Elevations in serum creatinine above 2.5 times the upper limit of normal.
  5. Use of drugs known to be with etonogestrel or efavirenz within 30 days of study entry. Due to the dynamic nature of drug interactions related to antiretroviral therapy, the study team will review all concomitant medications at screening for drug interactions with efavirenz and the etonogestrel implant.
  6. Currently pregnant or postpartum less than 30 days at study entry.
  7. Breastfeeding women within 6 months of delivery.
  8. Use of hormonal in the preceding 3 months prior to entry
  9. Participants determined to be ineligible for intrauterine device placement.
  10. Patients with a history of to etonogestrel implant, undiagnosed vaginal bleeding, diagnosed or suspected sex hormone dependent neoplasia, benign or malignant liver tumor, or thromboembolic disease.
  11. Presence of any active disease or life-threatening disease that, in the investigator's opinion, would compromise the subject's safety or outcome of the study.
Terms in these criteria, in plain language(9)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
72 participants (actual)

Study arms

  • Active comparator
    Standard Dose Etonogestrel Implant

    Single 68 mg etonogestrel implant

    Drug: etonogestrel implant

  • Experimental
    Increased Dose Etonogestrel Implant

    Two 68 mg (136 mg total) etonogestrel implants

    Drug: etonogestrel implant

Interventions

  • The etonogestrel implant is an contraceptive implant that is placed into the upper arm.

    Also known as: Nexplanon, Implanon

06

What researchers measure

Primary outcomes

  1. Proportion of Participants That Ovulate During Month 3

    Proportion of participants that experience at least one ovulation during month 3 of etonogestrel implant use. Serum progesterone concentrations are measured weekly during month 3 (weeks 9-12). Ovulation is defined as endogenous progesterone concentrations of \>3 ng/mL.

    Time frame: 3 months

  2. Proportion of Participants That Ovulate During Month 6

    Proportion of participants that experience at least one ovulation during month 6 of etonogestrel implant use. Serum progesterone concentrations are measured weekly during month 6 (weeks 21-24). Ovulation is defined as endogenous progesterone concentrations of \>3 ng/mL.

    Time frame: 6 months

  3. Proportion of Participants That Ovulate During Month 12

    Proportion of participants that experience at least one ovulation during month 12 of etonogestrel implant use. Serum progesterone concentrations are measured weekly during month 12 (weeks 45-48). Ovulation is defined as endogenous progesterone concentrations of \>3 ng/mL.

    Time frame: 12 months

Secondary outcomes

  1. Proportion of Cervical Mucus Scores Greater Than 10

    The proportion of World Health Organization cervical mucus scores that are greater than 10 from weekly samples collected during months 3, 6 and 12 of etonogestrel implant use. A cervical mucus score greater than 10 indicates the mucus is favorable for sperm penetration or lack of contraceptive effect. The cervical mucus score ranges from 0 indicating least favorable for sperm penetration to 15 for most favorable for sperm penetration.

    Time frame: 12 months

  2. Median Efavirenz Concentration at Enrollment

    Median efavirenz concentrations measured in plasma samples collected at enrollment, prior to insertion of the etonogestrel implant(s). Plasma efavirenz concentrations were quantified using a high-performance liquid chromatography assay with ultraviolet detection.

    Time frame: Day 0

  3. Median Efavirenz Concentration at Week 4

    Median efavirenz concentrations measured in plasma samples collected 4 weeks after insertion of the etonogestrel implant(s). Plasma efavirenz concentrations were quantified using a high-performance liquid chromatography assay with ultraviolet detection.

    Time frame: 4 weeks

  4. Median Efavirenz Concentration at Week 12

    Median efavirenz concentrations measured in plasma samples collected 12 weeks after insertion of the etonogestrel implant(s). Plasma efavirenz concentrations were quantified using a high-performance liquid chromatography assay with ultraviolet detection.

    Time frame: 12 weeks

  5. Median Efavirenz Concentration at Week 24

    Median efavirenz concentrations measured in plasma samples collected 24 weeks after insertion of the etonogestrel implant(s). Plasma efavirenz concentrations were quantified using a high-performance liquid chromatography assay with ultraviolet detection.

    Time frame: 24 weeks

  6. Median Efavirenz Concentration at Week 36

    Median efavirenz concentrations measured in plasma samples collected 36 weeks after insertion of the etonogestrel implant(s). Plasma efavirenz concentrations were quantified using a high-performance liquid chromatography assay with ultraviolet detection.

    Time frame: 36 weeks

  7. Median Efavirenz Concentration at Week 48

    Median efavirenz concentrations measured in plasma samples collected 48 weeks after insertion of the etonogestrel implant(s). Plasma efavirenz concentrations were quantified using a high-performance liquid chromatography assay with ultraviolet detection.

    Time frame: 48 weeks

  8. Median Etonogestrel Concentration at Week 1

    Median etonogestrel concentrations measured in plasma samples collected 1 week after insertion of the etonogestrel implant(s). Plasma etonogestrel concentrations were quantified using liquid chromatography tandem mass spectrometry.

    Time frame: 1 week

  9. Median Etonogestrel Concentration at Week 4

    Median etonogestrel concentrations measured in plasma samples collected 4 weeks after insertion of the etonogestrel implant(s). Plasma etonogestrel concentrations were quantified using liquid chromatography tandem mass spectrometry.

    Time frame: 4 weeks

  10. Median Etonogestrel Concentration at Week 12

    Median etonogestrel concentrations measured in plasma samples collected 12 weeks after insertion of the etonogestrel implant(s). Plasma etonogestrel concentrations were quantified using liquid chromatography tandem mass spectrometry.

    Time frame: 12 weeks

  11. Median Etonogestrel Concentration at Week 24

    Median etonogestrel concentrations measured in plasma samples collected 24 weeks after insertion of the etonogestrel implant(s). Plasma etonogestrel concentrations were quantified using liquid chromatography tandem mass spectrometry.

    Time frame: 24 weeks

  12. Median Etonogestrel Concentration at Week 36

    Median etonogestrel concentrations measured in plasma samples collected 36 weeks after insertion of the etonogestrel implant(s). Plasma etonogestrel concentrations were quantified using liquid chromatography tandem mass spectrometry.

    Time frame: 36 weeks

  13. Median Etonogestrel Concentration at Week 48

    Median etonogestrel concentrations measured in plasma samples collected 48 weeks after insertion of the etonogestrel implant(s). Plasma etonogestrel concentrations were quantified using liquid chromatography tandem mass spectrometry.

    Time frame: 48 weeks

07

Results

Posted Sep 5, 2024

Participant flow

Participant flow — Overall Study
MilestoneStandard Dose Etonogestrel ImplantIncreased Dose Etonogestrel Implant
Started3636
Completed3436
Not completed20
Withdrew: Pregnancy10
Withdrew: Physician decision10

Outcome measures

PrimaryProportion of Participants That Ovulate During Month 3

Proportion of participants that experience at least one ovulation during month 3 of etonogestrel implant use. Serum progesterone concentrations are measured weekly during month 3 (weeks 9-12). Ovulation is defined as endogenous progesterone concentrations of \>3 ng/mL.

Time frame:
3 months
Reported as:
Count of participants · Participants
Proportion of Participants That Ovulate During Month 3
ParticipantsStandard Dose Etonogestrel ImplantIncreased Dose Etonogestrel Implant
Proportion of Participants That Ovulate During Month 3110
Statistical analysis
  • Standard Dose Etonogestrel Implant vs Increased Dose Etonogestrel Implant · Fisher Exact · p = <.001
PrimaryProportion of Participants That Ovulate During Month 6

Proportion of participants that experience at least one ovulation during month 6 of etonogestrel implant use. Serum progesterone concentrations are measured weekly during month 6 (weeks 21-24). Ovulation is defined as endogenous progesterone concentrations of \>3 ng/mL.

Time frame:
6 months
Reported as:
Count of participants · Participants
Proportion of Participants That Ovulate During Month 6
ParticipantsStandard Dose Etonogestrel ImplantIncreased Dose Etonogestrel Implant
Proportion of Participants That Ovulate During Month 6170
Statistical analysis
  • Standard Dose Etonogestrel Implant vs Increased Dose Etonogestrel Implant · Fisher Exact · p = <.001
PrimaryProportion of Participants That Ovulate During Month 12

Proportion of participants that experience at least one ovulation during month 12 of etonogestrel implant use. Serum progesterone concentrations are measured weekly during month 12 (weeks 45-48). Ovulation is defined as endogenous progesterone concentrations of \>3 ng/mL.

Time frame:
12 months
Reported as:
Count of participants · Participants
Proportion of Participants That Ovulate During Month 12
ParticipantsStandard Dose Etonogestrel ImplantIncreased Dose Etonogestrel Implant
Proportion of Participants That Ovulate During Month 12192
Statistical analysis
  • Standard Dose Etonogestrel Implant vs Increased Dose Etonogestrel Implant · Fisher Exact · p = <.001
SecondaryProportion of Cervical Mucus Scores Greater Than 10

The proportion of World Health Organization cervical mucus scores that are greater than 10 from weekly samples collected during months 3, 6 and 12 of etonogestrel implant use. A cervical mucus score greater than 10 indicates the mucus is favorable for sperm penetration or lack of contraceptive effect. The cervical mucus score ranges from 0 indicating least favorable for sperm penetration to 15 for most favorable for sperm penetration.

Time frame:
12 months
Reported as:
Count of units · Cervical mucus samples
Proportion of Cervical Mucus Scores Greater Than 10
Cervical mucus samplesStandard Dose Etonogestrel ImplantIncreased Dose Etonogestrel Implant
Cervical mucus score greater than 1011
Cervical mucus score of 10 or less248233
Statistical analysis
  • Standard Dose Etonogestrel Implant vs Increased Dose Etonogestrel Implant · Fisher Exact · p = >.99
SecondaryMedian Efavirenz Concentration at Enrollment

Median efavirenz concentrations measured in plasma samples collected at enrollment, prior to insertion of the etonogestrel implant(s). Plasma efavirenz concentrations were quantified using a high-performance liquid chromatography assay with ultraviolet detection.

Time frame:
Day 0
Reported as:
Median · µg/mL
Median Efavirenz Concentration at Enrollment
µg/mLStandard Dose Etonogestrel ImplantIncreased Dose Etonogestrel Implant
Median Efavirenz Concentration at Enrollment2.26 (1.15 to 4.63)2.30 (1.28 to 3.65)
Statistical analysis
  • Standard Dose Etonogestrel Implant vs Increased Dose Etonogestrel Implant · Wilcoxon (Mann-Whitney) · p = .685
SecondaryMedian Efavirenz Concentration at Week 4

Median efavirenz concentrations measured in plasma samples collected 4 weeks after insertion of the etonogestrel implant(s). Plasma efavirenz concentrations were quantified using a high-performance liquid chromatography assay with ultraviolet detection.

Time frame:
4 weeks
Reported as:
Median · µg/mL
Median Efavirenz Concentration at Week 4
µg/mLStandard Dose Etonogestrel ImplantIncreased Dose Etonogestrel Implant
Median Efavirenz Concentration at Week 42.41 (1.47 to 4.26)2.23 (1.38 to 5.46)
Statistical analysis
  • Standard Dose Etonogestrel Implant vs Increased Dose Etonogestrel Implant · Wilcoxon (Mann-Whitney) · p = .784
SecondaryMedian Efavirenz Concentration at Week 12

Median efavirenz concentrations measured in plasma samples collected 12 weeks after insertion of the etonogestrel implant(s). Plasma efavirenz concentrations were quantified using a high-performance liquid chromatography assay with ultraviolet detection.

Time frame:
12 weeks
Reported as:
Median · µg/mL
Median Efavirenz Concentration at Week 12
µg/mLStandard Dose Etonogestrel ImplantIncreased Dose Etonogestrel Implant
Median Efavirenz Concentration at Week 122.10 (1.22 to 3.99)1.88 (1.35 to 2.87)
Statistical analysis
  • Standard Dose Etonogestrel Implant vs Increased Dose Etonogestrel Implant · Wilcoxon (Mann-Whitney) · p = .587
SecondaryMedian Efavirenz Concentration at Week 24

Median efavirenz concentrations measured in plasma samples collected 24 weeks after insertion of the etonogestrel implant(s). Plasma efavirenz concentrations were quantified using a high-performance liquid chromatography assay with ultraviolet detection.

Time frame:
24 weeks
Reported as:
Median · µg/mL
Median Efavirenz Concentration at Week 24
µg/mLStandard Dose Etonogestrel ImplantIncreased Dose Etonogestrel Implant
Median Efavirenz Concentration at Week 242.26 (1.31 to 4.12)1.76 (1.18 to 3.47)
Statistical analysis
  • Standard Dose Etonogestrel Implant vs Increased Dose Etonogestrel Implant · Wilcoxon (Mann-Whitney) · p = .394
SecondaryMedian Efavirenz Concentration at Week 36

Median efavirenz concentrations measured in plasma samples collected 36 weeks after insertion of the etonogestrel implant(s). Plasma efavirenz concentrations were quantified using a high-performance liquid chromatography assay with ultraviolet detection.

Time frame:
36 weeks
Reported as:
Median · µg/mL
Median Efavirenz Concentration at Week 36
µg/mLStandard Dose Etonogestrel ImplantIncreased Dose Etonogestrel Implant
Median Efavirenz Concentration at Week 361.97 (1.18 to 5.27)1.87 (1.09 to 4.28)
Statistical analysis
  • Standard Dose Etonogestrel Implant vs Increased Dose Etonogestrel Implant · Wilcoxon (Mann-Whitney) · p = .660
SecondaryMedian Efavirenz Concentration at Week 48

Median efavirenz concentrations measured in plasma samples collected 48 weeks after insertion of the etonogestrel implant(s). Plasma efavirenz concentrations were quantified using a high-performance liquid chromatography assay with ultraviolet detection.

Time frame:
48 weeks
Reported as:
Median · µg/mL
Median Efavirenz Concentration at Week 48
µg/mLStandard Dose Etonogestrel ImplantIncreased Dose Etonogestrel Implant
Median Efavirenz Concentration at Week 482.05 (1.36 to 3.66)1.72 (1.01 to 2.73)
Statistical analysis
  • Standard Dose Etonogestrel Implant vs Increased Dose Etonogestrel Implant · Wilcoxon (Mann-Whitney) · p = .290
SecondaryMedian Etonogestrel Concentration at Week 1

Median etonogestrel concentrations measured in plasma samples collected 1 week after insertion of the etonogestrel implant(s). Plasma etonogestrel concentrations were quantified using liquid chromatography tandem mass spectrometry.

Time frame:
1 week
Reported as:
Median · pg/mL
Median Etonogestrel Concentration at Week 1
pg/mLStandard Dose Etonogestrel ImplantIncreased Dose Etonogestrel Implant
Median Etonogestrel Concentration at Week 1182 (102 to 303)439 (327 to 618)
SecondaryMedian Etonogestrel Concentration at Week 4

Median etonogestrel concentrations measured in plasma samples collected 4 weeks after insertion of the etonogestrel implant(s). Plasma etonogestrel concentrations were quantified using liquid chromatography tandem mass spectrometry.

Time frame:
4 weeks
Reported as:
Median · pg/mL
Median Etonogestrel Concentration at Week 4
pg/mLStandard Dose Etonogestrel ImplantIncreased Dose Etonogestrel Implant
Median Etonogestrel Concentration at Week 4115 (79 to 178)282 (158 to 414)
SecondaryMedian Etonogestrel Concentration at Week 12

Median etonogestrel concentrations measured in plasma samples collected 12 weeks after insertion of the etonogestrel implant(s). Plasma etonogestrel concentrations were quantified using liquid chromatography tandem mass spectrometry.

Time frame:
12 weeks
Reported as:
Median · pg/mL
Median Etonogestrel Concentration at Week 12
pg/mLStandard Dose Etonogestrel ImplantIncreased Dose Etonogestrel Implant
Median Etonogestrel Concentration at Week 1283 (66 to 99)214 (124 to 271)
SecondaryMedian Etonogestrel Concentration at Week 24

Median etonogestrel concentrations measured in plasma samples collected 24 weeks after insertion of the etonogestrel implant(s). Plasma etonogestrel concentrations were quantified using liquid chromatography tandem mass spectrometry.

Time frame:
24 weeks
Reported as:
Median · pg/mL
Median Etonogestrel Concentration at Week 24
pg/mLStandard Dose Etonogestrel ImplantIncreased Dose Etonogestrel Implant
Median Etonogestrel Concentration at Week 2469 (41 to 99)168 (91 to 224)
SecondaryMedian Etonogestrel Concentration at Week 36

Median etonogestrel concentrations measured in plasma samples collected 36 weeks after insertion of the etonogestrel implant(s). Plasma etonogestrel concentrations were quantified using liquid chromatography tandem mass spectrometry.

Time frame:
36 weeks
Reported as:
Median · pg/mL
Median Etonogestrel Concentration at Week 36
pg/mLStandard Dose Etonogestrel ImplantIncreased Dose Etonogestrel Implant
Median Etonogestrel Concentration at Week 3654 (42 to 71)132 (75 to 157)
SecondaryMedian Etonogestrel Concentration at Week 48

Median etonogestrel concentrations measured in plasma samples collected 48 weeks after insertion of the etonogestrel implant(s). Plasma etonogestrel concentrations were quantified using liquid chromatography tandem mass spectrometry.

Time frame:
48 weeks
Reported as:
Median · pg/mL
Median Etonogestrel Concentration at Week 48
pg/mLStandard Dose Etonogestrel ImplantIncreased Dose Etonogestrel Implant
Median Etonogestrel Concentration at Week 4839 (25 to 64)95 (69 to 137)

Adverse events

Collected over 48 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Standard Dose Etonogestrel Implant0/36 (0%)0/36 (0%)35/36 (97.2%)
Increased Dose Etonogestrel Implant0/36 (0%)0/36 (0%)35/36 (97.2%)
Most frequent other events
Most frequent other events
EventStandard Dose Etonogestrel ImplantIncreased Dose Etonogestrel Implant
MenorrhagiaReproductive system and breast disorders23/3630/36
Implant Site ReactionProduct Issues15/3624/36
MetrorrhagiaReproductive system and breast disorders14/3622/36
HeadacheNervous system disorders16/3615/36
DysmenorrheaReproductive system and breast disorders8/3610/36
AcneSkin and subcutaneous tissue disorders9/366/36
Breast TendernessReproductive system and breast disorders1/364/36
NauseaGastrointestinal disorders4/364/36
AmenorrheaReproductive system and breast disorders2/363/36
Weight GainGeneral disorders1/363/36

Baseline characteristics

All enrolled participants

Age, Continuous
Age, Continuous(years)Standard Dose Etonogestrel ImplantIncreased Dose Etonogestrel ImplantTotal
Median32 (28 to 36)30 (29 to 35)31 (29 to 36)
Sex: Female, Male
Sex: Female, Male(Participants)Standard Dose Etonogestrel ImplantIncreased Dose Etonogestrel ImplantTotal
Female363672
Male000
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Standard Dose Etonogestrel ImplantIncreased Dose Etonogestrel ImplantTotal
Ganda221941
Nkore516
Nyarwanda235
Soga213
Tooro033
Kiga134
Other4610
Region of Enrollment
Region of Enrollment(participants)Standard Dose Etonogestrel ImplantIncreased Dose Etonogestrel ImplantTotal
Uganda363672
Weight
Weight(kg)Standard Dose Etonogestrel ImplantIncreased Dose Etonogestrel ImplantTotal
Median60.2 (54.0 to 69.1)59.2 (51.0 to 70.5)60.0 (52.6 to 69.4)
CD4+ cell count
CD4+ cell count(cells/mm3)Standard Dose Etonogestrel ImplantIncreased Dose Etonogestrel ImplantTotal
Median648 (602 to 923)700 (536 to 875)669 (547 to 880)
Prior live births
Prior live births(births)Standard Dose Etonogestrel ImplantIncreased Dose Etonogestrel ImplantTotal
Median3 (2.25 to 4)3 (2 to 3.75)3 (2 to 4)
08

Study locations

1 site
  • Infectious Disease Institute
    Kampala, Uganda
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2019 to primary completion in Dec 2020, 22 months.

Results were first posted in Sep 2024, 3 years 8 months after primary completion.

Of 57 non-industry phase 2 interventional studies under Acquired Immunodeficiency Syndrome, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 65. This study's 22 months is below that.

Counting every sponsor, half of 86 studies reached it within 36 months; a quarter within 18 and three quarters within 71.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 12, 2017
First posted
Sep 14, 2017
StartActual
Feb 19, 2019
Primary completionActual
Dec 22, 2020
CompletionActual
Oct 25, 2022
Results first posted
Sep 5, 2024
Last update
Sep 5, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03282799
Lead sponsor
Catherine Anne Chappell
Collaborators
Infectious Disease Institute, Kampala, Uganda, University of Nebraska
Responsible party
Catherine Anne Chappell (Assistant Professor, University of Pittsburgh) — Sponsor-investigator
First posted
Sep 14, 2017
Start date
Feb 19, 2019
Primary completion
Dec 22, 2020
Completion
Oct 25, 2022
Results posted
Sep 5, 2024
Last update
Sep 5, 2024

Study contacts

Catherine A Chappell, MD MSc
principal investigator · University of Pittsburgh

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Etonogestrel

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