ContraceptionPhase 2NCT00213096
Effects of Hormonal Contraceptives on Liver Proteins and Coagulation Factors: A Comparison of a Contraceptive Vaginal Ring and an Oral Contraceptive
A Phase 2 study testing Nestorone/ethinyl estradiol contraceptive vaginal ring; levonorgestrel/ethinyl estradiol oral contraceptive in people with Contraception, run by Population Council at 1 site in Netherlands.
Trial summary
The purpose of this 3-month (cycle) study was to evaluate the effects of hormonal contraceptives containing a progestin and an estrogen on liver proteins and coagulation factors that are sensitive to estrogen. Read more about this study
- Who is it for?
- Ages 18 to 34 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Nestorone/ethinyl estradiol contraceptive vaginal ring; levonorgestrel/ethinyl estradiol oral contraceptive
- Type of treatment
- Pill or oral medicine
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2003to Feb 2004
- Phase
- Phase 2
- 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 34 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy women, aged 18-34 years, who did not wish to become pregnant for 3 months (or 5 months if first discontinuing oral contraceptives
- Intact uterus and at least 1 ovary
- Have regular menstrual cycles (28 ± 7 days) or 2 regular cycles after parturition or abortion
- Willing to use condoms while having sexual intercourse during the 3 month study (or 5 months if discontinuing oral contraceptives), or
- Willing to continue use of a specified non-hormonal method of birth control including permanent sterilization, non-hormone-containing IUD, male condoms, or abstinence during the study or to use condoms if discontinuing one of these methods
- Willing and able to comply with the protocol
- Willing and able to sign informed consent prior to entry into the study and prior to discontinuing another method of contraception
- Easy venous access
Who cannot join
- Pregnancy
- Known hypersensitivity to estrogens or progestins
- Known hypersensitivity to silicone rubber
- Undiagnosed vaginal discharge or vaginal lesions or abnormalities
- Smoking status: >15 cigarettes per day
- Breastfeeding
Show all 25Show fewer
- Current or past thrombophlebitis or thromboembolic disorders
- Family history of venous thrombosis or embolism (1st degree relatives <55 years of age)
- Known history of Factor V Leiden or positive screening test for APC-resistance
- Current or past cerebrovascular or coronary artery disease
- Carcinoma (hormone-dependent tumor; past history of any carcinoma not in remission for >5 years)
- Medically diagnosed severe depression
- Headaches with focal neurological symptoms
- Undiagnosed abnormal genital bleeding
- History of cholestatic jaundice of pregnancy or jaundice with prior steroid use
- Benign or malignant liver tumors; active liver disease
- Diastolic/systolic BP ≥90/140 mmHg after 5 min. rest
- Known or suspected alcoholism (>2 drinks/day)or drug abuse
- Positive for hepatitis B \& C and/or HIV 1 or 2, abnormal screening CBC, serum chemistry values (including fasting, total cholesterol and triglycerides), abnormal Pap smear, abnormal findings on dipstick urinalysis, or an abnormal electrocardiogram (ECG)
- Participation in a clinical trial within last 3 months or more than 1 trial in the last year
- BMI (kg/m2) >28
- Use of injectable contraceptives in last 6 months (e.g. cyclofem or DMPA)
- Unwilling to stop oral contraceptives for 2 months prior to study initiation
- Use of implanted hormonal contraceptives, including Mirena or Implanon, in last 2 years
- Not living in the catchment area of the clinic*Severe cystoceles or rectoceles
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-Label Study Comparing the Effect of a Contraceptive Vaginal Ring Delivering Daily Doses of 150 Micrograms Nestorone and 15 Micrograms Ethinyl Estradiol to an Oral Contraceptive Containing 150 Micrograms of Levonorgestrel and 30 Micrograms of Ethinyl Estradiol Per Tablet on Hepatic Factors Including Coagulation Factors
The purpose of this 3-month (cycle) study was to evaluate the effects of hormonal contraceptives containing a progestin and an estrogen on liver proteins and coagulation factors that are sensitive to estrogen. In this study, a contraceptive vaginal ring containing Nestorone® (a progestin with no androgenic properties) and ethinyl estradiol was compared to an oral contraceptive containing levonorgestrel (an androgenic progestin) and ethinyl estradiol.
Read the detailed description
The purpose of this 3-month (cycle) study was to evaluate the effects of hormonal contraceptives containing a progestin and an estrogen on liver proteins and coagulation factors that are sensitive to estrogen. In this study, a contraceptive vaginal ring containing Nestorone® (a progestin with no androgenic properties) and ethinyl estradiol was compared to an oral contraceptive containing levonorgestrel (an androgenic progestin) and ethinyl estradiol.
- Conditions
- Contraception
- Being tested
- Nestorone/ethinyl estradiol contraceptive vaginal ring; levonorgestrel/ethinyl estradiol oral contraceptive
- Keywords
- Contraceptive agents, female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nestorone/ethinyl estradiol contraceptive vaginal ring; levonorgestrel/ethinyl estradiol oral contraceptiveDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the differences between contraceptive vaginal ring and oral contraceptive treatment groups in change from baseline to end of treatment in serum angiotensinogen and sex-hormone binding globulin.
Secondary outcomes (1)
Comparison of the differences between contraceptive vaginal ring & oral contraceptive treatment groups in change from baseline to end of treatment in serum or plasma concentrations of 15 other hepatic proteins, coagulation factors & coagulation markers.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startMar 2003
- Study completionFeb 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- Population Council
- Sponsor type
- University, hospital or other
- Collaborators
- United States Agency for International Development (USAID)
- Investigators
- Regine Sitruk-Ware, MD, Principal investigator, Population Council
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00213096
- Sponsor's protocol ID
- Population Council #323
- Other IDs
- HRN-A-00-99-00010
- Status last verified
- Aug 2017
- First submitted
- 13 Sep 2005
- Last updated
- 14 Aug 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label Study Comparing the Effect of a Contraceptive Vaginal Ring Delivering Daily Doses of 150 Micrograms Nestorone and 15 Micrograms Ethinyl Estradiol to an Oral Contraceptive Containing 150 Micrograms of Levonorgestrel and 30 Micrograms of Ethinyl Estradiol Per Tablet on Hepatic Factors Including Coagulation Factors
- ClinicalTrials.gov ID
- NCT00213096
- Acronym / sponsor ID
- Population Council #323
- Conditions
- Contraception
- Keywords
- Contraceptive agents, female
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- Population CouncilUniversity, hospital or other
- Collaborators
- United States Agency for International Development (USAID)
- Study start
- Mar 2003 (actual)
- Study completion
- Feb 2004 (actual)
- First posted
- 21 Sep 2005 (estimated)
- 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.
The purpose of this 3-month (cycle) study was to evaluate the effects of hormonal contraceptives containing a progestin and an estrogen on liver proteins and coagulation factors that are sensitive to estrogen. In this study, a contraceptive vaginal ring containing Nestorone® (a progestin with no androgenic properties) and ethinyl estradiol was compared to an oral contraceptive containing levonorgestrel (an androgenic progestin) and ethinyl estradiol.
Detailed description
The purpose of this 3-month (cycle) study was to evaluate the effects of hormonal contraceptives containing a progestin and an estrogen on liver proteins and coagulation factors that are sensitive to estrogen. In this study, a contraceptive vaginal ring containing Nestorone® (a progestin with no androgenic properties) and ethinyl estradiol was compared to an oral contraceptive containing levonorgestrel (an androgenic progestin) and ethinyl estradiol.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 34 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy women, aged 18-34 years, who did not wish to become pregnant for 3 months (or 5 months if first discontinuing oral contraceptives
- Intact uterus and at least 1 ovary
- Have regular menstrual cycles (28 ± 7 days) or 2 regular cycles after parturition or abortion
- Willing to use condoms while having sexual intercourse during the 3 month study (or 5 months if discontinuing oral contraceptives), or
- Willing to continue use of a specified non-hormonal method of birth control including permanent sterilization, non-hormone-containing IUD, male condoms, or abstinence during the study or to use condoms if discontinuing one of these methods
Key exclusion criteria (25 listed)
- Pregnancy
- Known hypersensitivity to estrogens or progestins
- Known hypersensitivity to silicone rubber
- Undiagnosed vaginal discharge or vaginal lesions or abnormalities
- Smoking status: >15 cigarettes per day
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 |
|---|---|---|
| Nestorone/ethinyl estradiol contraceptive vaginal ring; levonorgestrel/ethinyl estradiol oral contraceptive | Drug | – |
Primary outcome
Comparison of the differences between contraceptive vaginal ring and oral contraceptive treatment groups in change from baseline to end of treatment in serum angiotensinogen and sex-hormone binding globulin.
1 secondary outcome
Comparison of the differences between contraceptive vaginal ring & oral contraceptive treatment groups in change from baseline to end of treatment in serum or plasma concentrations of 15 other hepatic proteins, coagulation factors & coagulation markers.
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 14 Aug 2017.
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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.
Regine Sitruk-Ware, MD principal investigator
Population Council
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nestorone/ethinyl estradiol contraceptive vaginal ring; levonorgestrel/ethinyl estradiol oral contraceptive in people with Contraception, run by Population Council at 1 site in Netherlands.
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 8 inclusion and 25 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 14 Aug 2017. 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 Netherlands. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Comparison of the differences between contraceptive vaginal ring and oral contraceptive treatment groups in change from baseline to end of treatment in serum angiotensinogen and sex-hormone binding globulin.. 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 14 Aug 2017.