PharmacokineticsPhase 1NCT03737656
Characterization of the Pharmacokinetics of a Vaginal Ring With 2.0 g Progesterone in Post-menopausal Women
A Phase 1 study testing Progesterone vaginal ring in people with Pharmacokinetics, run by Grünenthal GmbH at 1 site in Mexico.
Trial summary
This is a single site, open-label, randomized, single-dose, Phase 1 study in post-menopausal women. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- Progesterone vaginal ring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteMexico
- Study dates
- 1 Nov 2018to 9 May 2019
- Phase
- Phase 1
- 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 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Only post-menopausal women aged between 40 years and 65 years who are currently not in hormone replacement therapy and who meet any of the following criteria:
- 12 months of spontaneous and continuous amenorrhea.
- 6 months of spontaneous amenorrhea with follicle-stimulating hormone levels above 40 international units/liter and less than 20 picograms per milliliter estradiol.
- Bilateral oophorectomy without hysterectomy.
- The body mass index must be between 18.5 and 29.99 kilograms per square meter according to the Quetelet index.
- Participants must be healthy determined by the results of a complete clinical history recorded by the clinical investigational site and the results of the laboratory examinations done by a certified clinical laboratory.
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- Participants with pre-existing illnesses must be controlled with stable doses of medication for a period of at least 3 months.
- The allowed limits of variation within normal in the screening visit will be: systolic blood pressure (sitting) less or equal to 130 mmHg, diastolic blood pressure less or equal to 80 mmHg, pulse rate between 50 and 100 beats per minute for 1 minute and respiratory rate between 14 and 20 breaths per minute.
- Laboratory and other examinations to be conducted for the inclusion of participants will be:
- Complete blood count: leukocytes, erythrocytes, hemoglobin, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, erythrocyte distribution width, platelets, neutrophils, lymphocytes, monocytes, eosinophils.
- Blood chemistry 27 elements: glucose, urea, blood urea nitrogen (BUN), creatinine, BUN/creatinine ratio, uric acid, cholesterol, high-density lipoprotein (HDL) cholesterol, triglycerides, low-density lipoprotein cholesterol, non-HDL cholesterol, atherogenic index, total protein, albumin, globulins, albumin/globulin ratio, total bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, total alkaline phosphatase, gamma-glutamyl transferase, lactate dehydrogenase, iron, calcium, sodium, potassium, and chloride.
- Urinalysis: Physical examination (color, appearance, density); chemical examination (pH, leukocytes, nitrite, protein, glucose, ketones, bilirubin, urobilinogen, hemoglobin); microscopic examination (leukocytes, erythrocytes, dysmorphic erythrocytes, casts, crystals, squamous epithelial cells, tubular renal cells, mucus, bacteria and yeasts).
- Hepatitis B screening (antibody to hepatitis B core antigen [Anti-HBc], antibody to hepatitis B surface antigen [HBs-Ab], antibody to hepatitis B surface antigen [Anti-HBs]) and hepatitis C antibodies.
- HIV test: Antibodies to the human immunodeficiency virus (Anti-HIV 1 and 2).
- Venereal disease research laboratory test (VDRL).
- Drugs of abuse test at the screening visit and approximately 12 hours before insertion of the vaginal ring on Day 1.
- Alcohol breath test approximately 12 hours before insertion of the vaginal ring on Day 1.
- Twelve-lead electrocardiogram (ECG) (with validity of no more than 3 months). The ECG will be performed after resting for 5 minutes in a sitting position.
- Gynecological profile:
- Follicle-stimulating hormone.
- Serum estradiol.
- Luteinizing hormone.
- Transvaginal ultrasound (without clinically significant findings).
- Pap smear without clinically significant findings.
- Bilateral mammography (with Breast Imaging Reporting and Data System [BI-RADS] 1 or 2 results).
Who cannot join
- Participants who do not meet the inclusion criteria described in the above section.
- Participants with a history of the following diseases: cardiovascular (myocardial infarction, not-controlled hypertension, thromboembolic, arterial or venous diseases), renal (kidney failure), hepatic (hepatitis, cholestatic jaundice, hepatic tumors, Dubin-Johnson syndrome, Rotor syndrome), muscular, metabolic, gastrointestinal including constipation, neurologic (cerebrovascular disease), endocrinological (not-controlled diabetes), hematopoietic or any type of anemia, history of toxic shock due to Staphylococcus, asthma, mental disorder (depression) or other organic abnormalities that are not appropriately controlled and that require a pharmacological treatment that could result in a drug interaction with the study medication. Women who have had muscular trauma within 21 days previous to the study will also be excluded.
- Participants with uterine bleeding.
- Participants with endometrial thickness equal to or greater than 7 millimeters as determined in the transvaginal ultrasound.
- Participants with history of dyspepsia, gastritis, esophagitis, duodenal or gastric ulcer.
- Hypersensitivity or allergy to the study medication.
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- Participants who have been exposed to medications known to be enzyme inducers or inhibitors or women who have taken potentially toxic medications within 72 hours previous to the start of each study period.
- Participants undergoing hormone replacement therapy or taking thyroid hormones in the last 3 months.
- Participants who have been hospitalized for any reason within 6 months prior to study start.
- Participants who have taken investigational medicinal products from other investigations within 180 days (i.e., 6 months) prior to study start.
- Participants who have smoked tobacco within 12 hours prior to study days 1, 28, and 91.
- Participants who have donated or lost more than 450 milliliters of blood within 60 days prior to study start.
- Participants with a history of drug abuse or alcoholism.
- Participants requiring a special diet for any reason e.g., vegetarian.
- Participants unable to understand the nature, objectives, and possible consequences of the study.
- Evidence of the participant's uncooperativeness during the conduct of the study.
- Positive results for drugs of abuse (in urine) or alcohol breath tests.
- Participants who are not registered in the Mexico Ministry of Health (Comisión Federal para la Protección contra Riesgos Sanitarios [COFEPRIS]) webpage.
- Relationship of subordination between the participants and the investigators.
- Sponsor or clinical site employees.
- Discontinuation criteria:
- Participants may be discontinued from the study at the discretion of the Clinic Director among others, because of the following reasons:
- Safety and well-being of the participant.
- Lack of adherence to the procedures and therefore non-compliance with the protocol.
- Medical reasons: adverse reactions to the study medication classified as severe.
- Recurring or intercurrent disease (not controlled).
- Withdrawal of consent to participate in the study.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Investigacíon Farmacológica y Biofarmacéutica (IFaB), S.A.P.I. de C.V.
Mexico City, C.P. 14610
About this study
Official title: Open-label, Randomized, Clinical Trial With Three Groups for the Characterization of Pharmacokinetics of a Vaginal Ring With 2.0 g Progesterone in Post-menopausal Women
This is a single site, open-label, randomized, single-dose, Phase 1 study in post-menopausal women.
Read the detailed description
The objective of the study is to characterize the pharmacokinetics of progesterone in post-menopausal women after the insertion of a vaginal ring containing 2.0 g of progesterone. Progesterone is slowly released from the ring within 90 days (sustained-release). Study participants will use the vaginal ring for a period of 91 days (13 weeks).
Progesterone blood concentrations will be determined during the use of the vaginal ring and after removal of the vaginal ring after a period of use of 13 weeks. In subgroups of participants, progesterone blood concentrations will also be determined after removal of the ring for a period of 2 hours or 4 hours on Day 28 of use. A study participant has completed the study when the final evaluation takes place, which is 7-15 days after removal of the vaginal ring on Day 91.
The safety of the progesterone vaginal ring will be assessed based on the adverse events reported.
- Conditions
- Pharmacokinetics
- Being tested
- Progesterone vaginal ring
- Keywords
- Progesterone, Vaginal ring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progesterone vaginal ringDrug
Also called Progering (Trade Mark)
Vaginal ring with 2.0 g progesterone (sustained-release over 90-days)
| Study group | Role | What they receive |
|---|---|---|
| Progesterone Vaginal Ring (Group A) | Experimental | Insertion of the vaginal ring on Day 1 and continuous use until 91 days of treatment are completed. In this group, 28 participants will be included. Receives: Drug: Progesterone vaginal ring |
| Progesterone Vaginal Ring (Group B) | Experimental | Insertion of the vaginal ring on Day 1, removal for 2 hours on study Day 28, re-insertion on Day 28, and continuous use for 63 days until 91 days of treatment are completed. In this group, 6 participants will be included. Receives: Drug: Progesterone vaginal ring |
| Progesterone Vaginal Ring (Group C) | Experimental | Insertion of the vaginal ring on Day 1, removal for 4 hours on study Day 28, re-insertion on Day 28, and continuous use for 63 days until 91 days of treatment are completed. In this group, 6 participants will be included. Receives: Drug: Progesterone vaginal ring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progesterone pharmacokinetic parameters (AUC0-t)
In Groups A, B, and C, 3 blood samples will be obtained before the device is placed and 24 samples after placement of the device up to Day 91. Additional samples (6 samples in Group B and 8 samples in Group C) will be taken while the ring is removed/after the ring is re-inserted on Day 28. Eight blood samples will be taken from all participants (from Groups A, B, and C) within 24 hours after the ring is removed on Day 91. Plasma concentrations of progesterone will be determined using validated analytical methods. The baseline-corrected and uncorrected area under the plasma concentration-time curve from 0 to time t (AUC0-t) will be calculated.
Measured: Insertion of ring (Day 1) to removal of ring (Day 91) plus 24 hours
Progesterone pharmacokinetic parameters (AUC0-inf)
In Groups A, B, and C, 3 blood samples will be obtained before the device is placed and 24 samples after placement of the device up to Day 91. Additional samples (6 samples in Group B and 8 samples in Group C) will be taken while the ring is removed/after the ring is re-inserted on Day 28. Eight blood samples will be taken from all participants (from Groups A, B, and C) within 24 hours after the ring is removed on Day 91. Plasma concentrations of progesterone will be determined using validated analytical methods. The baseline-corrected and uncorrected area under the plasma concentration-time curve from 0 to infinity (AUC0-inf) will be calculated.
Measured: Insertion of ring (Day 1) to removal of ring (Day 91) plus 24 hours
Progesterone pharmacokinetic parameters (Cmax)
In Groups A, B, and C, 3 blood samples will be obtained before the device is placed and 24 samples after placement of the device up to Day 91. Additional samples (6 samples in Group B and 8 samples in Group C) will be taken while the ring is removed/after the ring is re-inserted on Day 28. Eight blood samples will be taken from all participants (from Groups A, B, and C) within 24 hours after the ring is removed on Day 91. Plasma concentrations of progesterone will be determined using validated analytical methods. The baseline-corrected and uncorrected maximum plasma concentration (Cmax) will be calculated.
Measured: Insertion of ring (Day 1) to removal of ring (Day 91) plus 24 hours
Secondary outcomes (4)
Progesterone pharmacokinetic parameters (Tmax)
In Groups A, B, and C, 3 blood samples will be obtained before the device is placed and 24 samples after placement of the device up to Day 91. Additional samples (6 samples in Group B and 8 samples in Group C) will be taken while the ring is removed/after the ring is re-inserted on Day 28. Eight blood samples will be taken from all participants (from Groups A, B, and C) within 24 hours after the ring is removed on Day 91. Plasma concentrations of progesterone will be determined using validated analytical methods. The time to achieve maximum plasma concentration (tmax) will be calculated.
Measured: Insertion of ring (Day 1) to removal of ring (Day 91) plus 24 hours
Progesterone pharmacokinetic parameters (AUC%extr)
In Groups A, B, and C, 3 blood samples will be obtained before the device is placed; 24 samples after placement of the device up to Day 91. Additional samples (6 samples in Group B and 8 samples in Group C) will be taken while the ring is removed/after the ring is re-inserted on Day 28. Eight blood samples will be taken from all participants (from Groups A, B, and C) within 24 hours after the ring is removed on Day 91. Plasma concentrations of progesterone will be determined using validated analytical methods. The extrapolated area under the plasma concentration-time curve (AUC%extr) will be calculated based on AUC0-t and AUC0-inf.
Measured: Insertion of ring (Day 1) to removal of ring (Day 91) plus 24 hours
Progesterone pharmacokinetic parameters (t1/2)
In Groups A, B, and C, 3 blood samples will be obtained before the device is placed and 24 samples after placement of the device up to Day 91. Additional samples (6 samples in Group B and 8 samples in Group C) will be taken while the ring is removed/after the ring is re-inserted on Day 28. Eight blood samples will be taken from all participants (from Groups A, B, and C) within 24 hours after the ring is removed on Day 91. Plasma concentrations of progesterone will be determined using validated analytical methods. The elimination half-time (t1/2) will be calculated.
Measured: Insertion of ring (Day 1) to removal of ring (Day 91) plus 24 hours
Progesterone pharmacokinetic parameters (MRT)
In Groups A, B, and C, 3 blood samples will be obtained before the device is placed; 24 samples after placement of the device up to Day 91. Additional samples (6 samples in Group B and 8 samples in Group C) will be taken while the ring is removed/after the ring is re-inserted on Day 28. Eight blood samples will be taken from all participants (from Groups A, B, and C) within 24 hours after the ring is removed on Day 91. Plasma concentrations of progesterone will be determined using validated analytical methods. The mean residence time (MRT) will be calculated.
Measured: Insertion of ring (Day 1) to removal of ring (Day 91) plus 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2018
- Study start1 Nov 2018
- Primary completion3 May 2019
- Study completion9 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single site, open-label, randomized, single-dose, with three groups.
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grünenthal GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Grünenthal, S.A.
- Responsible party
- Sponsor
- Investigators
- Grünenthal Study Director, Study director, Grünenthal GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03737656
- Sponsor's protocol ID
- PRG-02-GRU/PK-PVR-01
- Other IDs
- 16-CI-19 039 043, HP8013-01
- Status last verified
- Jun 2019
- First submitted
- 8 Nov 2018
- Last updated
- 5 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Information available on the Grünenthal Web Site (see URL below for details)
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Randomized, Clinical Trial With Three Groups for the Characterization of Pharmacokinetics of a Vaginal Ring With 2.0 g Progesterone in Post-menopausal Women
- ClinicalTrials.gov ID
- NCT03737656
- Acronym / sponsor ID
- PRG-02-GRU/PK-PVR-01
- Conditions
- Pharmacokinetics
- Keywords
- Progesterone, Vaginal ring
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Grünenthal GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Grünenthal, S.A.
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 3 May 2019 (actual)
- Study completion
- 9 May 2019 (actual)
- First posted
- 9 Nov 2018 (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.
This is a single site, open-label, randomized, single-dose, Phase 1 study in post-menopausal women.
Detailed description
The objective of the study is to characterize the pharmacokinetics of progesterone in post-menopausal women after the insertion of a vaginal ring containing 2.0 g of progesterone. Progesterone is slowly released from the ring within 90 days (sustained-release). Study participants will use the vaginal ring for a period of 91 days (13 weeks).
Progesterone blood concentrations will be determined during the use of the vaginal ring and after removal of the vaginal ring after a period of use of 13 weeks. In subgroups of participants, progesterone blood concentrations will also be determined after removal of the ring for a period of 2 hours or 4 hours on Day 28 of use. A study participant has completed the study when the final evaluation takes place, which is 7-15 days after removal of the vaginal ring on Day 91.
The safety of the progesterone vaginal ring will be assessed based on the adverse events reported.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Single site, open-label, randomized, single-dose, with three groups.
| Arm | Type | Receives |
|---|---|---|
| Progesterone Vaginal Ring (Group A) | Experimental | Drug: Progesterone vaginal ringInsertion of the vaginal ring on Day 1 and continuous use until 91 days of treatment are completed. In this group, 28 participants will be included. |
| Progesterone Vaginal Ring (Group B) | Experimental | Drug: Progesterone vaginal ringInsertion of the vaginal ring on Day 1, removal for 2 hours on study Day 28, re-insertion on Day 28, and continuous use for 63 days until 91 days of treatment are completed. In this group, 6 participants will be included. |
| Progesterone Vaginal Ring (Group C) | Experimental | Drug: Progesterone vaginal ringInsertion of the vaginal ring on Day 1, removal for 4 hours on study Day 28, re-insertion on Day 28, and continuous use for 63 days until 91 days of treatment are completed. In this group, 6 participants will be included. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Only post-menopausal women aged between 40 years and 65 years who are currently not in hormone replacement therapy and who meet any of the following criteria:
- 12 months of spontaneous and continuous amenorrhea.
- 6 months of spontaneous amenorrhea with follicle-stimulating hormone levels above 40 international units/liter and less than 20 picograms per milliliter estradiol.
- Bilateral oophorectomy without hysterectomy.
- The body mass index must be between 18.5 and 29.99 kilograms per square meter according to the Quetelet index.
Key exclusion criteria (27 listed)
- Participants who do not meet the inclusion criteria described in the above section.
- Participants with a history of the following diseases: cardiovascular (myocardial infarction, not-controlled hypertension, thromboembolic, arterial or venous diseases), renal (kidney failure), hepatic (hepatitis, cholestatic jaundice, hepatic tumors, Dubin-Johnson syndrome, Rotor syndrome), muscular, metabolic, gastrointestinal including constipation, neurologic (cerebrovascular disease), endocrinological (not-controlled diabetes), hematopoietic or any type of anemia, history of toxic shock due to Staphylococcus, asthma, mental disorder (depression) or other organic abnormalities that are not appropriately controlled and that require a pharmacological treatment that could result in a drug interaction with the study medication. Women who have had muscular trauma within 21 days previous to the study will also be excluded.
- Participants with uterine bleeding.
- Participants with endometrial thickness equal to or greater than 7 millimeters as determined in the transvaginal ultrasound.
- Participants with history of dyspepsia, gastritis, esophagitis, duodenal or gastric ulcer.
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 |
|---|---|---|
| Progesterone vaginal ringAlso: Progering (Trade Mark)Vaginal ring with 2.0 g progesterone (sustained-release over 90-days) | Drug | Progesterone Vaginal Ring (Group A), Progesterone Vaginal Ring (Group B), Progesterone Vaginal Ring (Group C) |
Primary outcome
Progesterone pharmacokinetic parameters (AUC0-t)
Time frame: Insertion of ring (Day 1) to removal of ring (Day 91) plus 24 hours
In Groups A, B, and C, 3 blood samples will be obtained before the device is placed and 24 samples after placement of the device up to Day 91. Additional samples (6 samples in Group B and 8 samples in Group C) will be taken while the ring is removed/after the ring is re-inserted on Day 28. Eight blood samples will be taken from all participants (from Groups A, B, and C) within 24 hours after the ring is removed on Day 91. Plasma concentrations of progesterone will be determined using validated analytical methods. The baseline-corrected and uncorrected area under the plasma concentration-time curve from 0 to time t (AUC0-t) will be calculated.
Progesterone pharmacokinetic parameters (AUC0-inf)
Time frame: Insertion of ring (Day 1) to removal of ring (Day 91) plus 24 hours
In Groups A, B, and C, 3 blood samples will be obtained before the device is placed and 24 samples after placement of the device up to Day 91. Additional samples (6 samples in Group B and 8 samples in Group C) will be taken while the ring is removed/after the ring is re-inserted on Day 28. Eight blood samples will be taken from all participants (from Groups A, B, and C) within 24 hours after the ring is removed on Day 91. Plasma concentrations of progesterone will be determined using validated analytical methods. The baseline-corrected and uncorrected area under the plasma concentration-time curve from 0 to infinity (AUC0-inf) will be calculated.
Progesterone pharmacokinetic parameters (Cmax)
Time frame: Insertion of ring (Day 1) to removal of ring (Day 91) plus 24 hours
In Groups A, B, and C, 3 blood samples will be obtained before the device is placed and 24 samples after placement of the device up to Day 91. Additional samples (6 samples in Group B and 8 samples in Group C) will be taken while the ring is removed/after the ring is re-inserted on Day 28. Eight blood samples will be taken from all participants (from Groups A, B, and C) within 24 hours after the ring is removed on Day 91. Plasma concentrations of progesterone will be determined using validated analytical methods. The baseline-corrected and uncorrected maximum plasma concentration (Cmax) will be calculated.
4 secondary outcomes
Progesterone pharmacokinetic parameters (Tmax)
Time frame: Insertion of ring (Day 1) to removal of ring (Day 91) plus 24 hours
Progesterone pharmacokinetic parameters (AUC%extr)
Time frame: Insertion of ring (Day 1) to removal of ring (Day 91) plus 24 hours
Progesterone pharmacokinetic parameters (t1/2)
Time frame: Insertion of ring (Day 1) to removal of ring (Day 91) plus 24 hours
Progesterone pharmacokinetic parameters (MRT)
Time frame: Insertion of ring (Day 1) to removal of ring (Day 91) plus 24 hours
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 5 Jun 2019.
- Individual participant dataSharing planned: Yes. Information available on the Grünenthal Web Site (see URL below for details)
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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.
Grünenthal Study Director study director
Grünenthal GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Progesterone vaginal ring in people with Pharmacokinetics, run by Grünenthal GmbH at 1 site in Mexico.
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 25 inclusion and 27 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 5 Jun 2019. 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 Mexico. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Progesterone pharmacokinetic parameters (AUC0-t) (time frame: Insertion of ring (Day 1) to removal of ring (Day 91) plus 24 hours). The study lists 3 primary outcomes in all. 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 5 Jun 2019.