NCT03282799

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2019

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2017

Completed
1.4 years until next milestone

Study Start

First participant enrolled

February 19, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2020

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2022

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

September 5, 2024

Completed
Last Updated

September 5, 2024

Status Verified

August 1, 2024

Enrollment Period

1.8 years

First QC Date

September 12, 2017

Results QC Date

March 14, 2024

Last Update Submit

August 30, 2024

Conditions

HIV/AIDSContraception

Keywords

etonogestrelefavirenzantiretroviral therapyHIV

Outcome Measures

Primary Outcomes (3)

  • 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

Secondary Outcomes (13)

  • Proportion of Cervical Mucus Scores Greater Than 10

    12 months

  • Median Efavirenz Concentration at Enrollment

    Day 0

  • Median Efavirenz Concentration at Week 4

    4 weeks

  • Median Efavirenz Concentration at Week 12

    12 weeks

  • Median Efavirenz Concentration at Week 24

    24 weeks

  • +8 more secondary outcomes

Study Arms (2)

Standard Dose Etonogestrel Implant

ACTIVE COMPARATOR

Single 68 mg etonogestrel implant

Drug: etonogestrel implant

Increased Dose Etonogestrel Implant

EXPERIMENTAL

Two 68 mg (136 mg total) etonogestrel implants

Drug: etonogestrel implant

Interventions

etonogestrel implantDRUG

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

Also known as: Nexplanon, Implanon
Increased Dose Etonogestrel ImplantStandard Dose Etonogestrel Implant

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study.
  • Participants who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
  • Women aged 18 years to 40 years.
  • Diagnosed with HIV infection.
  • Medically eligible for the etonogestrel subdermal implant as a contraceptive method.
  • Receiving efavirenz-based anti-retroviral therapy for a minimum of 3 months prior to screening.
  • Must agree to have concurrent highly effective non-hormonal contraception with a copper intrauterine device, if not previously medically sterilized.
  • Participants must report regular menses (bleeding for 4-8 days at 21- to 35-day intervals) for the preceding 2 months.
  • 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.

You may not qualify if:

  • HIV RNA \> 50 copies/mL at screening visit.
  • Serum hemoglobin \< 10.0 g/dL.
  • Elevations in serum levels of alanine transaminase above 5 times the upper limit of normal.
  • Elevations in serum creatinine above 2.5 times the upper limit of normal.
  • Use of drugs known to be contraindicated 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.
  • Currently pregnant or postpartum less than 30 days at study entry.
  • Breastfeeding women within 6 months of delivery.
  • Use of hormonal contraception in the preceding 3 months prior to entry
  • Participants determined to be ineligible for intrauterine device placement.
  • Patients with a history of hypersensitivity to etonogestrel implant, undiagnosed vaginal bleeding, diagnosed or suspected sex hormone dependent neoplasia, benign or malignant liver tumor, or thromboembolic disease.
  • Presence of any active clinically significant disease or life-threatening disease that, in the investigator's opinion, would compromise the subject's safety or outcome of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Infectious Disease Institute

Kampala, Uganda

Location

Related Publications (1)

  • 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.

    PMID: 38458408DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

etonogestrel

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Results Point of Contact

Title
Dr. Catherine Chappell
Organization
University of Pittsburgh
chappelca@upmc.edu
412-641-1403

Study Officials

  • Catherine A Chappell, MD MSc

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 12, 2017

First Posted

September 14, 2017

Study Start

February 19, 2019

Primary Completion

December 22, 2020

Study Completion

October 25, 2022

Last Updated

September 5, 2024

Results First Posted

September 5, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

UG(1)