Contraceptive UsageNCT00612508
Hormonal Contraception and Vaginal Health
A study testing Desogen (ethinyl estradiol and desogestrel) and NuvaRing (ethinyl estradiol and etonogestrel) in people with Contraceptive Usage and Vaginal Epithelial Disruption, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The purpose of this study is to help determine if the route by which women receive hormonal contraception causes different changes to occur in the lining of the vagina. The investigators plan to compare an oral route (taking birth control pills) with a vaginal route (using a vaginal ring). Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraceptive Usage, Vaginal Epithelial Disruption
- What is being tested?
- Desogen (ethinyl estradiol and desogestrel) and NuvaRing (ethinyl estradiol and etonogestrel)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to May 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female
- 18-35 years
- In general good health
- With regular menses (every 28-32 days)
- Seeking contraception and willing to use a hormonal method for at least 6 months
Who cannot join
- Current or recent (within the past 8 weeks) vaginitis or pelvic inflammatory disease
- History of recurrent vaginitis (> 2 episodes in one year, any type)
- Pregnancy
- Recent use of hormonal contraceptives
- Depot medroxyprogesterone: 6 months
- Progestin implants: 3 months
Show all 22Show fewer
- Oral contraceptives: 3 months
- Hormone impregnated IUD: 3 months
- Contraindications to use of oral contraceptive pills or vaginal ring
- History of deep vein thrombosis
- Known coagulopathy or thrombophilia
- Unexplained vaginal bleeding
- Uncontrolled hypertension
- Diabetes with vascular changes
- Present or history of hepatic disease or liver tumors
- Migraines with neurologic changes
- Myocardial infection
- Pulmonary embolus
- Stroke
- Breast cancer
- Hypersensitivity or allergy to hormonal contraception
- Heavy Smoking ( ≥ 15 cigarettes per day)
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health and Science University
Portland, Oregon, 97239
About this study
Official title: The Effects of Oral vs. Intravaginal Hormonal Contraception on Vaginal Health
The purpose of this study is to help determine if the route by which women receive hormonal contraception causes different changes to occur in the lining of the vagina. The investigators plan to compare an oral route (taking birth control pills) with a vaginal route (using a vaginal ring).
Read the detailed description
The investigators intend to conduct a prospective, randomized study at Oregon Health and Science University. This study will be conducted over six 28-day cycles. Subjects enrolled in the study will undergo baseline vaginal biopsy and then be randomized to receive either intravaginal ethinyl estradiol and etonogestrel (NuvaRing®) or oral ethinyl estradiol and desogestrel (Desogen®). Repeat vaginal biopsies will be obtained after three and six months of exposure to either oral or intravaginal hormonal contraception. These will be analyzed to measure the thickness of the vaginal epithelium and to quantify the presence of Langerhans cell, macrophages, T-lymphocytes and dendritic cells.
- Conditions
- Contraceptive Usage, Vaginal Epithelial Disruption
- Being tested
- Desogen (ethinyl estradiol and desogestrel), NuvaRing (ethinyl estradiol and etonogestrel)
- Keywords
- contraception, NuvaRing, Desogen, vaginal biopsy
- Medical subject headings
- Contraception Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Desogen (ethinyl estradiol and desogestrel)Drug
Also called Desogen®
1 tablet every day; each tablet contains 0.15mg desogestrel and 0.03mg ethinyl estradiol
NuvaRing (ethinyl estradiol and etonogestrel)Drug
Also called NuvaRing®
Place the ring in the vagina for 3 weeks, remove for one week. Repeat with new Ring
| Study group | Role | What they receive |
|---|---|---|
| Desogen | Active comparator | Drug: ethinyl estradiol and desogestrel
1 tablet every day; each tablet contains 0.15mg desogestrel and 0.03mg ethinyl estradiol; secen inactive pills every 28 days.
Subjects receive baseline vaginal biopsy, followed by treatment with the OC for six cycles and repeat biopsy at 3 and after 6 cycles Receives: Drug: Desogen (ethinyl estradiol and desogestrel) |
| NuvaRing | Active comparator | Intravaginal Contraception
ethinyl estradiol (0.15 mg/d) and etonogestrel (0.12 mg/d) Place the ring in the vagina for 3 weeks, remove for one week. Repeat with new Ring
Subjects had baseline vaginal biopsy followed by 6 cycles of ring use and repeat biopsy at 3 and after 6 cycles Receives: Drug: NuvaRing (ethinyl estradiol and etonogestrel) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thickness of the Vaginal Epithelium (in mm)With Means and Standard Deviations Reported.
Histologic evalation of vaginal sections was performed to measured and record the absolute thickness of the vaginal epithelium. Baseline findings were compared to biopsies after three and six cycles of treatment. Mean values were compared using T-test for paired data for baseline and 84 days, and baseline and 168 days
Measured: baseline, 84 days, 168 days
Secondary outcomes (1)
Adverse Events
Self-reported treatment-related and serious adverse events
Measured: over 168 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2008 (estimated)
- Study startMay 2007
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Contraceptive UsageStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon Clinical and Translational Research Institute
- Responsible party
- Principal investigator, Jeffrey Jensen, Oregon Health and Science University
- Investigators
- Jeffrey T Jensen, MD., MPH, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00612508
- Sponsor's protocol ID
- OHSU RES 2017
- Status last verified
- Oct 2012
- First submitted
- 29 Jan 2008
- Last updated
- 8 Nov 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Oral vs. Intravaginal Hormonal Contraception on Vaginal Health
- ClinicalTrials.gov ID
- NCT00612508
- Acronym / sponsor ID
- OHSU RES 2017
- Conditions
- Contraceptive Usage, Vaginal Epithelial Disruption
- Keywords
- contraception, NuvaRing, Desogen, vaginal biopsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Oregon Clinical and Translational Research Institute
- Study start
- May 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 11 Feb 2008 (estimated)
- Results
- Posted 8 Nov 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to help determine if the route by which women receive hormonal contraception causes different changes to occur in the lining of the vagina. The investigators plan to compare an oral route (taking birth control pills) with a vaginal route (using a vaginal ring).
Detailed description
The investigators intend to conduct a prospective, randomized study at Oregon Health and Science University. This study will be conducted over six 28-day cycles. Subjects enrolled in the study will undergo baseline vaginal biopsy and then be randomized to receive either intravaginal ethinyl estradiol and etonogestrel (NuvaRing®) or oral ethinyl estradiol and desogestrel (Desogen®). Repeat vaginal biopsies will be obtained after three and six months of exposure to either oral or intravaginal hormonal contraception. These will be analyzed to measure the thickness of the vaginal epithelium and to quantify the presence of Langerhans cell, macrophages, T-lymphocytes and dendritic cells.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Desogen | Active comparator | Drug: Desogen (ethinyl estradiol and desogestrel)Drug: ethinyl estradiol and desogestrel 1 tablet every day; each tablet contains 0.15mg desogestrel and 0.03mg ethinyl estradiol; secen inactive pills every 28 days. Subjects receive baseline vaginal biopsy, followed by treatment with the OC for six cycles and repeat biopsy at 3 and after 6 cycles |
| NuvaRing | Active comparator | Drug: NuvaRing (ethinyl estradiol and etonogestrel)Intravaginal Contraception ethinyl estradiol (0.15 mg/d) and etonogestrel (0.12 mg/d) Place the ring in the vagina for 3 weeks, remove for one week. Repeat with new Ring Subjects had baseline vaginal biopsy followed by 6 cycles of ring use and repeat biopsy at 3 and after 6 cycles |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Female
- 18-35 years
- In general good health
- With regular menses (every 28-32 days)
- Seeking contraception and willing to use a hormonal method for at least 6 months
Key exclusion criteria (22 listed)
- Current or recent (within the past 8 weeks) vaginitis or pelvic inflammatory disease
- History of recurrent vaginitis (> 2 episodes in one year, any type)
- Pregnancy
- Recent use of hormonal contraceptives
- Depot medroxyprogesterone: 6 months
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 |
|---|---|---|
| Desogen (ethinyl estradiol and desogestrel)Also: Desogen®1 tablet every day; each tablet contains 0.15mg desogestrel and 0.03mg ethinyl estradiol | Drug | Desogen |
| NuvaRing (ethinyl estradiol and etonogestrel)Also: NuvaRing®Place the ring in the vagina for 3 weeks, remove for one week. Repeat with new Ring | Drug | NuvaRing |
Primary outcome
Thickness of the Vaginal Epithelium (in mm)With Means and Standard Deviations Reported.
Time frame: baseline, 84 days, 168 days
Histologic evalation of vaginal sections was performed to measured and record the absolute thickness of the vaginal epithelium. Baseline findings were compared to biopsies after three and six cycles of treatment. Mean values were compared using T-test for paired data for baseline and 84 days, and baseline and 168 days
1 secondary outcome
Adverse Events
Time frame: over 168 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- (Women's Health Research Unit website)Link provided by the sponsor.
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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.
Jeffrey T Jensen, MD., MPH principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Desogen (ethinyl estradiol and desogestrel) and NuvaRing (ethinyl estradiol and etonogestrel) in people with Contraceptive Usage and Vaginal Epithelial Disruption, run by Oregon Health and Science University at 1 site in United States.
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 5 inclusion and 22 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 8 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Thickness of the Vaginal Epithelium (in mm)With Means and Standard Deviations Reported. (time frame: baseline, 84 days, 168 days). 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 8 Nov 2012.