Mucosal InflammationPhase 4UMPALANCT04814927
Impact of Contraceptives on Cervico-Vaginal Mucosa
A Phase 4 study testing Copper IUD, Etonogestrel implant and Levonorgestrel IUS in people with Mucosal Inflammation and Contraceptive; Complications, Intrauterine, run by Eastern Virginia Medical School at 2 sites in 2 countries.
Trial summary
UMPALA is a research study to look at the effect of four different, approved contraceptives on the cervical and vaginal tissues as well as on factors in the blood. Participants will have a baseline examination then receive one of four approved, marketed contraceptive products. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mucosal Inflammation, Contraceptive; Complications, Intrauterine
- What is being tested?
- Copper IUD, Etonogestrel implant and Levonorgestrel IUS
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Mar 2021to 15 Dec 2022
- Phase
- Phase 4
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18 to 50 years, inclusive
- In general good health without any significant systemic disease and with an intact uterus and cervix.
- History of Pap smears and follow-up consistent with standard, local clinical practice or willing to undergo a Pap smear at Visit 1
- Willing to give voluntary consent and sign an informed consent form
- Willing and able to comply with protocol requirements, including accepting randomization to study contraceptive products
- If currently on a contraceptive product, willing to go off products and use condoms for birth control for a specified time
- If in a relationship, must be with a partner who is not known to be HIV positive and has no know risk of sexually transmitted infections (STIs)
Who cannot join
- Positive pregnancy test or plans to become pregnant during the course of the study
- Currently exclusively breastfeeding or planning to exclusively breastfeed during the course of the study
- Less than six weeks from a delivery of an infant greater than 20 weeks gestation
- Use of DMPA in the past 4 months
- Clinical signs and symptoms of menopause
- Current WHO or CDC medical eligibility criteria level 3 or 4 for any contraceptive product to which a participant could receive at the clinical site
Show all 16Show fewer
- History of sensitivity/allergy to any component of the study product, topical anesthetic, or to both silver nitrate and Monsel's solution
- Current infection with Trichomonas vaginalis (TV), Neisseria gonorrhea (NG), Chlamydia trachomatis (CT)
- Current positive test for HIV
- History of a pulmonary embolus or deep vein thrombosis
- Chronic or acute vulvar or vaginal symptoms (pain, irritation, spotting/bleeding, discharge, etc)
- Known blood disorder, eg. von Willebrands disease, that could lead to prolonged or continuous bleeding with biopsy
- Chronic use systemic corticosteroids, antibiotics, antimycobacterials, anticoagulants or other drugs known to prolong bleeding and/or promote clotting, antifungals, or antivirals or antiretrovirals.
- Current or anticipated chronic use of non-steroidal anti-inflammatory drugs (NSAIDs) or acetaminophen for the duration of the study
- Participation in any other investigational trial with use of a drug/device within the last 30 days or planned participation in any other investigational trial with use of a drug/device during the study
- Abnormal finding on laboratory or physical examination or a social or medical condition in which, in the opinion of the investigator, would make participation in the study unsafe or would complicate interpretation of the data
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Eastern Virginia Medical School
Norfolk, Virginia, 23507
About this study
Official title: The UMPALA Study: A Clinical Study to Assess the Impact of Contraceptives on the Cervico-Vaginal Mucosa
UMPALA is a research study to look at the effect of four different, approved contraceptives on the cervical and vaginal tissues as well as on factors in the blood. Participants will have a baseline examination then receive one of four approved, marketed contraceptive products. Cervico-vaginal assessments will take place 4 weeks after contraceptive initiation and 3 months after to assess changes in mucosal safety after use of various contraceptive products in young, healthy, HIV uninfected women.
Read the detailed description
This clinical study will complete approximately 12 healthy, non-pregnant, HIV-uninfected women aged 18-50 years per contraceptive arm, who are at low risk for sexually transmitted infections (STIs) at two clinical sites, for a total of approximately 96 completed participants. The study will examine changes from baseline, pre-contraceptive dosing to post contraceptive dosing of cervico-vaginal mucosal safety and adverse events.
Participants at each site will be randomized (1:1:1:1) to one of four, marketed, approved contraceptive dosing forms: Levonorgestrel (LNG) 52 mg. Intrauterine System (IUS), Copper Intrauterine Device (IUD), etonogestrel (ETG, Nexplanon, Implanon) contraceptive implant, or DMPA SC contraceptive injection.
Enrollment is expected to take approximately 8 months and each participant is expected to complete the study within 4 months.
- Being tested
- Copper IUD, Etonogestrel implant, Levonorgestrel IUS, DMPA Sub-cutaneous
- Keywords
- Contraception, Reproductive health, Copper IUD, Etonogestrel implant, DMPA sub-cutaneous, Levonorgestrel IUS
- Medical subject headings
- Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Copper IUDDrug
Also called Paragard
Participants randomized to Copper IUD will receive Paragard IUD at Visit 2.
Etonogestrel implantDrug
Also called Nexplanon, Implanon
Participants randomized to ETG implant will receive the implant at Visit 2.
Levonorgestrel IUSDrug
Also called Mirena, Liletta
Participants randomized to LNG intrauterine system will receive the IUS at Visit 2.
DMPA Sub-cutaneousDrug
Also called Subcutaneous depot medroxyprogesterone acetate
Participants randomized to DMPA SC will receive the injection at Visit 2.
| Study group | Role | What they receive |
|---|---|---|
| Copper IUD | Active comparator | The copper IUD contains approximately 176 mg of copper wire wrapped around a vertical stem. It is FDA approved for pregnancy prevention for 10 years. Receives: Drug: Copper IUD |
| Etonogestrel Implant | Active comparator | The ETG implant is a single, radiopaque, rod shaped implant containing 68 mg of etonogestrel. It is FDA approved for pregnancy prevention for 3 years. Receives: Drug: Etonogestrel implant |
| Levonorgestrel IUS | Active comparator | The LNG IUS contains approximately 52 mg. of LNG. It is FDA approved for pregnancy prevention for 5 - 6 years. Receives: Drug: Levonorgestrel IUS |
| DMPA Sub-cutaneous | Active comparator | DMPA contains 104 mg of medroxyprogesterone acetate in 0.65 mL of fluid, administered by subcutaneous injection in the abdominal fat, thigh or skin over the deltoid muscle. It is FDA approved for pregnancy prevention for 14 weeks. Receives: Drug: DMPA Sub-cutaneous |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with changes to mucosal function
Evaluate mucosal factors and microbiome changes from baseline associated with mucosal function and reproductive health, including vaginal glycogen, pH, lactic acid, soluble markers and immune cells.
Measured: 4 weeks and 3 months after product use
Number of participants with changes to mucosal health
Evaluate mucosal factors and microbiome changes from baseline associated with mucosal function and reproductive health, including vaginal glycogen, pH, lactic acid, soluble markers and immune cells.
Measured: 4 weeks and 3 months after product use
Secondary outcomes (1)
Number of participants with systemic inflammation
Evaluate changes from baseline in systemic factors associated with reproductive health, including C reactive protein and hormone concentrations.
Measured: 4 weeks and 3 months after product use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start1 Mar 2021
- Primary completion15 Dec 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mucosal InflammationStudies 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 4
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants at each site will receive one of four marketed, approved contraceptive products for the duration of the study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Virginia Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- CONRAD, Kenya Medical Research Institute, United States Agency for International Development (USAID)
- Responsible party
- Sponsor
- Investigators
- Andrea Thurman, Principal investigator, Eastern Virginia Medical School, CONRAD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04814927
- Sponsor's protocol ID
- CONRAD D20-149
- Acronym
- UMPALA
- Status last verified
- Aug 2023
- First submitted
- 18 Mar 2021
- Last updated
- 25 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Njoroge B, Mugo N, Herrera C, Dominguez K, Ouattara LA, Yousefieh N, Chandra N, Kurczewska A, Nartey S, Lewis J, Thurman AR, Saina M, Fichorova RN, Ravel J, Sharaf Alddin R, Richardson-Harman N, Ngure K, Doncel GF. Impact of contraceptive initiation on the cervicovaginal mucosa: results from the UMPALA multicentre, partially randomized patient-preference interventional trial. Front Reprod Health. 2026 Oct 2;8:1882772. doi: 10.3389/frph.2026.1882772. eCollection 2026.
PubMed 42890951
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The UMPALA Study: A Clinical Study to Assess the Impact of Contraceptives on the Cervico-Vaginal Mucosa
- ClinicalTrials.gov ID
- NCT04814927
- Acronym / sponsor ID
- UMPALA / CONRAD D20-149
- Keywords
- Contraception, Reproductive health, Copper IUD, Etonogestrel implant, DMPA sub-cutaneous, Levonorgestrel IUS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Eastern Virginia Medical SchoolUniversity, hospital or other
- Collaborators
- CONRAD, Kenya Medical Research Institute, United States Agency for International Development (USAID)
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 24 Mar 2021 (actual)
- 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.
UMPALA is a research study to look at the effect of four different, approved contraceptives on the cervical and vaginal tissues as well as on factors in the blood. Participants will have a baseline examination then receive one of four approved, marketed contraceptive products. Cervico-vaginal assessments will take place 4 weeks after contraceptive initiation and 3 months after to assess changes in mucosal safety after use of various contraceptive products in young, healthy, HIV uninfected women.
Detailed description
This clinical study will complete approximately 12 healthy, non-pregnant, HIV-uninfected women aged 18-50 years per contraceptive arm, who are at low risk for sexually transmitted infections (STIs) at two clinical sites, for a total of approximately 96 completed participants. The study will examine changes from baseline, pre-contraceptive dosing to post contraceptive dosing of cervico-vaginal mucosal safety and adverse events.
Participants at each site will be randomized (1:1:1:1) to one of four, marketed, approved contraceptive dosing forms: Levonorgestrel (LNG) 52 mg. Intrauterine System (IUS), Copper Intrauterine Device (IUD), etonogestrel (ETG, Nexplanon, Implanon) contraceptive implant, or DMPA SC contraceptive injection.
Enrollment is expected to take approximately 8 months and each participant is expected to complete the study within 4 months.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Participants at each site will receive one of four marketed, approved contraceptive products for the duration of the study.
| Arm | Type | Receives |
|---|---|---|
| Copper IUD | Active comparator | Drug: Copper IUDThe copper IUD contains approximately 176 mg of copper wire wrapped around a vertical stem. It is FDA approved for pregnancy prevention for 10 years. |
| Etonogestrel Implant | Active comparator | Drug: Etonogestrel implantThe ETG implant is a single, radiopaque, rod shaped implant containing 68 mg of etonogestrel. It is FDA approved for pregnancy prevention for 3 years. |
| Levonorgestrel IUS | Active comparator | Drug: Levonorgestrel IUSThe LNG IUS contains approximately 52 mg. of LNG. It is FDA approved for pregnancy prevention for 5 - 6 years. |
| DMPA Sub-cutaneous | Active comparator | Drug: DMPA Sub-cutaneousDMPA contains 104 mg of medroxyprogesterone acetate in 0.65 mL of fluid, administered by subcutaneous injection in the abdominal fat, thigh or skin over the deltoid muscle. It is FDA approved for pregnancy prevention for 14 weeks. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age 18 to 50 years, inclusive
- In general good health without any significant systemic disease and with an intact uterus and cervix.
- History of Pap smears and follow-up consistent with standard, local clinical practice or willing to undergo a Pap smear at Visit 1
- Willing to give voluntary consent and sign an informed consent form
- Willing and able to comply with protocol requirements, including accepting randomization to study contraceptive products
Key exclusion criteria (16 listed)
- Positive pregnancy test or plans to become pregnant during the course of the study
- Currently exclusively breastfeeding or planning to exclusively breastfeed during the course of the study
- Less than six weeks from a delivery of an infant greater than 20 weeks gestation
- Use of DMPA in the past 4 months
- Clinical signs and symptoms of menopause
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 |
|---|---|---|
| Copper IUDAlso: ParagardParticipants randomized to Copper IUD will receive Paragard IUD at Visit 2. | Drug | Copper IUD |
| Etonogestrel implantAlso: Nexplanon, ImplanonParticipants randomized to ETG implant will receive the implant at Visit 2. | Drug | Etonogestrel Implant |
| Levonorgestrel IUSAlso: Mirena, LilettaParticipants randomized to LNG intrauterine system will receive the IUS at Visit 2. | Drug | Levonorgestrel IUS |
| DMPA Sub-cutaneousAlso: Subcutaneous depot medroxyprogesterone acetateParticipants randomized to DMPA SC will receive the injection at Visit 2. | Drug | DMPA Sub-cutaneous |
Primary outcome
Number of participants with changes to mucosal function
Time frame: 4 weeks and 3 months after product use
Evaluate mucosal factors and microbiome changes from baseline associated with mucosal function and reproductive health, including vaginal glycogen, pH, lactic acid, soluble markers and immune cells.
Number of participants with changes to mucosal health
Time frame: 4 weeks and 3 months after product use
Evaluate mucosal factors and microbiome changes from baseline associated with mucosal function and reproductive health, including vaginal glycogen, pH, lactic acid, soluble markers and immune cells.
1 secondary outcome
Number of participants with systemic inflammation
Time frame: 4 weeks and 3 months after product use
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 25 Aug 2023.
- Derived from this study: PubMed 42890951Njoroge B, Mugo N, Herrera C, Dominguez K, Ouattara LA, Yousefieh N, Chandra N, Kurczewska A, Nartey S, Lewis J, Thurman AR, Saina M, Fichorova RN, Ravel J, Sharaf Alddin R, Richardson-Harman N, Ngure K, Doncel GF. Impact of contraceptive initiation on the cervicovaginal mucosa: results from the UMPALA multicentre, partially randomized patient-preference interventional trial. Front Reprod Health. 2026 Oct 2;8:1882772. doi: 10.3389/frph.2026.1882772. eCollection 2026.
- Individual participant dataSharing planned: No
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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.
Andrea Thurman principal investigator
Eastern Virginia Medical School, CONRAD
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Copper IUD, Etonogestrel implant and Levonorgestrel IUS in people with Mucosal Inflammation and Contraceptive; Complications, Intrauterine, run by Eastern Virginia Medical School at 2 sites in 2 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 16 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 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Kenya. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Number of participants with changes to mucosal function (time frame: 4 weeks and 3 months after product use). The study lists 2 primary outcomes in all. 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 NCT04814927, which also lists 1 linked publication.
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 25 Aug 2023.