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| Name | Class |
|---|---|
| Infectious Disease Institute, Kampala, Uganda | OTHER |
| University of Nebraska | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Dose Etonogestrel Implant | Active Comparator | Single 68 mg etonogestrel implant |
|
| Increased Dose Etonogestrel Implant | Experimental | Two 68 mg (136 mg total) etonogestrel implants |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etonogestrel implant | Drug | The etonogestrel implant is an contraceptive implant that is placed into the upper arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
| 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. | 6 months |
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catherine A Chappell, MD MSc | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Infectious Disease Institute | Kampala | Uganda |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38458408 | Derived | Chappell CA, Lamorde M, Nakalema S, Kyohairwe I, Byakika-Kibwika P, Meyn LA, Pham MM, Scarsi KK. A randomized trial of double vs single-dose etonogestrel implant to overcome the interaction with efavirenz-based antiretroviral therapy. Am J Obstet Gynecol. 2024 Aug;231(2):242.e1-242.e9. doi: 10.1016/j.ajog.2024.03.001. Epub 2024 Mar 7. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Dose Etonogestrel Implant | Single 68 mg etonogestrel implant etonogestrel implant: The etonogestrel implant is an contraceptive implant that is placed into the upper arm. |
| FG001 | Increased Dose Etonogestrel Implant | Two 68 mg (136 mg total) etonogestrel implants etonogestrel implant: The etonogestrel implant is an contraceptive implant that is placed into the upper arm. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All enrolled participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Dose Etonogestrel Implant | Single 68 mg etonogestrel implant etonogestrel implant: The etonogestrel implant is an contraceptive implant that is placed into the upper arm. |
| BG001 | Increased Dose Etonogestrel Implant |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | One participant in the standard dose arm was withdrawn at week 1 of the study due to pregnancy. | Posted | Count of Participants | Participants | 3 months |
|
48 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Dose Etonogestrel Implant | Single 68 mg etonogestrel implant etonogestrel implant: The etonogestrel implant is an contraceptive implant that is placed into the upper arm. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Amenorrhea | Reproductive system and breast disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Catherine Chappell | University of Pittsburgh | 412-641-1403 | chappelca@upmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 26, 2021 | Aug 28, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 11, 2017 | Dec 6, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C044815 | etonogestrel |
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|
| 12 months |
| 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. | Day 0 |
| 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. | 4 weeks |
| 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. | 12 weeks |
| 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. | 24 weeks |
| 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. | 36 weeks |
| 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. | 48 weeks |
| 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. | 1 week |
| 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. | 4 weeks |
| 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. | 12 weeks |
| 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. | 24 weeks |
| 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. | 36 weeks |
| 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. | 48 weeks |
Two 68 mg (136 mg total) etonogestrel implants
etonogestrel implant: The etonogestrel implant is an contraceptive implant that is placed into the upper arm.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Median | Inter-Quartile Range | kg |
|
| CD4+ cell count | Median | Inter-Quartile Range | cells/mm3 |
|
| Prior live births | Median | Inter-Quartile Range | births |
|
Two 68 mg (136 mg total) etonogestrel implants etonogestrel implant: The etonogestrel implant is an contraceptive implant that is placed into the upper arm. |
|
|
|
| Primary | 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. | One participant in the standard dose arm was withdrawn at week 1 of the study due to pregnancy. | Posted | Count of Participants | Participants | 6 months |
|
|
|
|
| Primary | 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. | One participant in the standard dose arm was withdrawn at week 1 of the study due to pregnancy, and one was withdrawn at week 45 due to a mental health condition. | Posted | Count of Participants | Participants | 12 months |
|
|
|
|
| Secondary | 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. | Evaluable cervical mucus samples collected from participants over 48 weeks of etonogestrel implant use. One participant in the standard dose arm was withdrawn at week 1 of the study due to pregnancy. | Posted | Count of Units | Cervical mucus samples | 12 months | Cervical mucus samples | Cervical mucus samples |
|
|
|
|
| Secondary | 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. | Efavirenz concentration not evaluated for 1 participant who was discontinued due to pregnancy at 1 week. | Posted | Median | Inter-Quartile Range | µg/mL | Day 0 |
|
|
|
|
| Secondary | 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. | Efavirenz concentration not evaluated for 1 participant who was discontinued due to pregnancy at 1 and 1 participant who missed the 4-week visit. | Posted | Median | Inter-Quartile Range | µg/mL | 4 weeks |
|
|
|
|
| Secondary | 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. | Efavirenz concentration not evaluated for 1 participant who was discontinued due to pregnancy at 1 week and 1 participant who missed the 12-week visit. | Posted | Median | Inter-Quartile Range | µg/mL | 12 weeks |
|
|
|
|
| Secondary | 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. | Efavirenz concentration not evaluated for 1 participant who was discontinued due to pregnancy at 1 week. | Posted | Median | Inter-Quartile Range | µg/mL | 24 weeks |
|
|
|
|
| Secondary | 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. | Efavirenz concentration not evaluated for 1 participant who was discontinued due to pregnancy at 1 week. | Posted | Median | Inter-Quartile Range | µg/mL | 36 weeks |
|
|
|
|
| Secondary | 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. | Efavirenz concentration not evaluated for 1 participant who was discontinued due to pregnancy at 1 week and 1 participant who missed the 48-week visit. | Posted | Median | Inter-Quartile Range | µg/mL | 48 weeks |
|
|
|
|
| Secondary | 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. | Etonogestrel concentration not evaluated for 1 participant who was discontinued due to pregnancy at 1 week. | Posted | Median | Inter-Quartile Range | pg/mL | 1 week |
|
|
|
| Secondary | 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. | Etonogestrel concentration not evaluated for 1 participant who was discontinued due to pregnancy at 1 week and 1 participant who missed the 4-week visit. | Posted | Median | Inter-Quartile Range | pg/mL | 4 weeks |
|
|
|
| Secondary | 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. | Etonogestrel concentration not evaluated for 1 participant who was discontinued due to pregnancy at 1 week and 1 participant who missed the 12-week visit. | Posted | Median | Inter-Quartile Range | pg/mL | 12 weeks |
|
|
|
| Secondary | 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. | Etonogestrel concentration not evaluated for 1 participant who was discontinued due to pregnancy at 1 week. | Posted | Median | Inter-Quartile Range | pg/mL | 24 weeks |
|
|
|
| Secondary | 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. | Etonogestrel concentration not evaluated for 1 participant who was discontinued due to pregnancy at 1 week. | Posted | Median | Inter-Quartile Range | pg/mL | 36 weeks |
|
|
|
| Secondary | 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. | Etonogestrel concentration not evaluated for 1 participant who was discontinued due to pregnancy at 1 week and 1 participant who missed the 48-week visit. | Posted | Median | Inter-Quartile Range | pg/mL | 48 weeks |
|
|
|
| 0 |
| 36 |
| 0 |
| 36 |
| 35 |
| 36 |
| EG001 | Increased Dose Etonogestrel Implant | Two 68 mg (136 mg total) etonogestrel implants etonogestrel implant: The etonogestrel implant is an contraceptive implant that is placed into the upper arm. | 0 | 36 | 0 | 36 | 35 | 36 |
| Menorrhagia | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Metrorrhagia | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Dysmenorrhea | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Weight Gain | General disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Breast Tenderness | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Implant Site Reaction | Product Issues | Non-systematic Assessment |
|
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |