Suppression of OvulationPhase 2NCT01586000
A Dose-finding Study to Evaluate the Effect of a Contraceptive Vaginal Ring, Releasing Nestorone® and Estradiol, on Cycle Control, Ovulation Inhibition, and Pharmacokinetics in Normal Cycling Women
A Phase 2 study testing 10 µg/day E2 with NES 200® µg/day, 20 µg/day E2 with NES 200® µg/day and 40 µg/day E2 with NES 200® µg/day in people with Suppression of Ovulation, run by Kimberly Myer at 8 sites in United States.
Trial summary
This clinical trial is an experimental research study using a potential new form of birth control. Clinical trials include people who volunteer to take part in a study. Take your time to decide if you want to be part of this experimental research study. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Suppression of Ovulation
- What is being tested?
- 10 µg/day E2 with NES 200® µg/day, 20 µg/day E2 with NES 200® µg/day and 40 µg/day E2 with NES 200® µg/day
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 197 participants
- Where
- 8 sitesUnited States
- Study dates
- Mar 2012to May 2015
- Phase
- Phase 2
- 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 39 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women who meet all the following criteria are eligible for enrollment in the trial:
- Healthy women of reproductive age (18-39 years, inclusive, at the enrollment visit).
- Have a regular menstrual cycle that is 21-35 days in duration.
- Have intact uterus and both ovaries.
- Will be able and willing to comply with the protocol and sign an informed consent.
- Will not be at risk for pregnancy. They will be consistently using a non-hormonal method, have a surgically sterile male partner with a vasectomy, be abstinent, or be in a same-sex relationship from the control period through study exit (including recovery period).
- Will have diastolic blood pressure (BP) ≤85 mm Hg and systolic BP ≤135 mm Hg after 5 minutes in sitting position.
- Willing to abstain from use of non-water based vaginal lubricant during the study.
Who cannot join
- Women who meet any of the following criteria are not eligible for enrollment in the trial:
- Participating in another clinical trial involving an investigational product within the last 30 days (prior to screening) or planning to participate in another clinical trial during this study.
- Not living in the catchment area of the clinic.
- Known hypersensitivity to progestins or estrogen.
- All contraindications to combined estrogen-progestin contraceptive use including:
- Thrombophlebitis or thromboembolic disorders.
Show all 50Show fewer
- Past personal history of deep vein thrombophlebitis or thromboembolic disorders.
- History of venous thrombosis or embolism in a first-degree relative <55 years of age suggesting familial defect in blood coagulation system, which in the opinion of the investigator, suggests use of a hormonal contraceptive could pose a significant risk.
- History of stroke.
- Known or suspected carcinoma of the breast.
- Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia.
- Undiagnosed abnormal genital bleeding.
- Cholestatic jaundice of pregnancy or jaundice with prior oral contraceptive use.
- Hepatic adenomas or carcinomas.
- Known or suspected pregnancy.
- Smoking in women who are 35 years and over or will be 35 years during the course of the trial; women <35 years who smoke 15 cigarettes or more per day must be evaluated by the investigator for inclusion based on risk factors that would increase their risk for cardiovascular disease (CVD) and thromboembolism, e.g. lipid levels, glucose level, BP, BMI, family history of CVD at a young age.
- History of retinal vascular lesions, unexplained partial or complete loss of vision.
- Headaches with focal neurological symptoms (e.g., migraines with auras).
- Desire to become pregnant during the study.
- Breastfeeding.
- Undiagnosed vaginal discharge or vaginal lesions or abnormalities. Subjects diagnosed at screening with a Chlamydia or gonococcus infection may be included in the trial following treatment; partner treatment is also recommended. Subjects with vaginitis (yeast, trichomonas, or bacterial vaginitis) may be enrolled after treatment. Investigators should make a determination if subjects are at high risk for reinfection, e.g. multiple sex partners, untreated partner, and whether such subjects can be included. In accordance with PI/medical designee assessment and local standards of practice, women with a history of genital herpes can be included if outbreaks are infrequent.
- A clinically significant Pap test abnormality, as managed by current local or national guidelines. Women with a current abnormal Pap (within the last nine months):
- In accordance with the Bethesda system of classification: smear suggestive of high-grade pre-cancerous lesion(s), including high grade squamous intraepithelial lesions (HGSILs), are excluded;
- Women with low grade squamous intraepithelial lesion (LGSIL) or atypical squamous cells of undetermined significance (ASCUS)/high-risk human papillomavirus (HPV) positive, or Atypical squamous cells, cannot rule out a high grade lesion (ASC-H) may participate if further evaluated with colposcopy and biopsy determines no evidence of a lesion with a severity greater than cervical intraepithelial neoplasia (CIN) I.
- Women with a biopsy finding of CIN I should have follow-up for this finding per standard of care; women are excluded if treatment is indicated.
- In accordance with other Pap class systems:
- Women with high grade dysplasia are excluded.
- Women with low grade dysplasia or CIN I interpretation on Pap test may participate following exclusion of a high grade lesion by colposcopic evaluation based on Investigator discretion and provided there is appropriate follow up in accordance with local standards.
- Known benign or malignant liver tumors; known active liver disease.
- Invasive cancer (past history of any carcinoma or sarcoma, except non-melanoma skin cancer).
- Current or past medically diagnosed severe depression, which, in the opinion of the investigator, could be exacerbated by use of a hormonal contraceptive.
- Known or suspected current alcoholism or drug abuse.
- Elevated serum fasting clinical chemistry values or complete blood count (CBC) values designated clinically significant by the investigator or medically qualified sub-investigator.
- Uncontrolled thyroid disease.
- Known impaired hypothalamic-pituitary-adrenal reserve.
- Body mass index (BMI) >35.
- Use of injectable contraceptives (e.g. cyclofem or depo-medroxyprogesterone acetate) during the 6 months prior to enrollment or no spontaneous menses since last injection.
- Use of oral contraceptives within one month prior to start of control cycle (subjects must undergo informed consent process and screening procedures before stopping oral contraceptives to participate in the study).
- Use of hormonal contraceptives. NOTE: Removal of implanted hormonal contraceptives must have been for personal reasons unrelated to the purpose of enrollment in this study.
- Current use of an intrauterine device (IUD). NOTE: Removal of an IUD must have been for personal reasons unrelated to the purpose of enrollment in this study.
- Known hypersensitivity to silicone rubber.
- History of toxic shock syndrome.
- Cystoceles or rectoceles or other anatomical abnormality that would preclude use of a vaginal ring.
- Planning to undergo major surgery during the study.
- Severe constipation.
- Use of liver enzyme inducers or inhibitors on a regular basis.
- Known HIV infection.
- Bariatric surgery within the past year prior to enrollment.
- Any abnormalities found during the transvaginal ultrasound (TVUS) that the PI or medically qualified sub-investigator deems to put the subject at risk.
- Have issues or concerns (in the judgment of the investigator) that may compromise the safety of the subject or confound the reliability of compliance and information acquired in this study.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Johns Hopkins School of Medicine
Baltimore, Maryland, 21224
University of Cincinnati
Cincinnati, Ohio, 45267
NYU School of Medicine
New York, New York, 10016
Columbia University
New York, New York, 10032
Eastern Virginia Medical School
Norfolk, Virginia, 23507
University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, 19104
Univeristy of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, 15213
Oregon Health & Science University
Portland, Oregon, 97239
About this study
This clinical trial is an experimental research study using a potential new form of birth control. Clinical trials include people who volunteer to take part in a study. Take your time to decide if you want to be part of this experimental research study. If you want to know more about this study first, ask the study doctor or study site staff. The investigators can also give you the study information written for doctors and clinic staff.
- Conditions
- Suppression of Ovulation
- Being tested
- 10 µg/day E2 with NES 200® µg/day, 20 µg/day E2 with NES 200® µg/day, 40 µg/day E2 with NES 200® µg/day
- Keywords
- vaginal ring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10 µg/day E2 with NES 200® µg/dayDrug
10 µg/day E2 with NES 200® µg/day delivered by CVR continuously for 6 months (180 days)
20 µg/day E2 with NES 200® µg/dayDrug
20 µg/day E2 with NES 200® µg/day delivered by CVR continuously for 6 months (180 days)
40 µg/day E2 with NES 200® µg/dayDrug
40 µg/day E2 with NES 200® µg/day delivered by CVR continuously for 6 months (180 days)
| Study group | Role | What they receive |
|---|---|---|
| 10 µg/day E2 | Experimental | Two consecutive 3-month (90-day) rings will be used continuously for six months (180 days). Receives: Drug: 10 µg/day E2 with NES 200® µg/day |
| 20 µg/day E2 | Experimental | Two consecutive 3-month (90-day) rings will be used continuously for six months (180 days). Receives: Drug: 20 µg/day E2 with NES 200® µg/day |
| 40 µg/day E2 | Experimental | Two consecutive 3-month (90-day) rings will be used continuously for six months (180 days). Receives: Drug: 40 µg/day E2 with NES 200® µg/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Days Bleeding is Reported.
The primary outcome will be the number of days that bleeding or spotting is reported in the first 3 cycles (90 days) of treatment.
Measured: Three months
Secondary outcomes (31)
Number of Subjects With Ovulation at During Each Cycle
A subject will be considered to have ovulated if she has two consecutive progesterone values of ≥10 nmol/L (≥3 ng/mL) preceded by a follicular measurement of >10 mm in the previous 10 days. Number of subjects considered to have ovulated during each cycle is reported.
Measured: Control Cycle 1, Treatment Cycles 2, 3, and 7, Recovery Cycle 8, up to 8 months
Area Under the Curve of NES and E2 at Specified Time Points
Pharmacokinetic assessments will be performed to measure absorption in a substudy of 22 women (7-8 in each dose group) at a single center (Oregon Health and Science University) at initiation of each ring use and at final ring removal. Blood will be collected for measurements before insertion of the first ring (at Visit 12), before removal of the second ring (at Visit 41), and at 2, 4, 6, 8, 10, 12, 24, 48 and approximately 72 hours after the first ring is inserted (at Visit 12) and after the second ring is removed (at Visit 41). PK samples will also be collected at the time of removal of the first ring (0 hours) at Visit 32, 2 hours after removal of the first ring and insertion of the second ring, and at 24 hours after removal of the first ring and insertion of the second ring.
Measured: Visits 12, 32, and 41 (Treatment Period)
The Safety of Administering 200 µg/Day of NES and One of Three Doses (10, 20, or 40 µg/Day) of E2 Delivered by CVR Continuously for 6 Months (180 Days).
Clinical safety will be evaluated by collection of adverse events (AEs).
Measured: Through Recovery Cycle 8, up to 8 months
Number of Days Bleeding is Reported.
The primary outcome will be the number of days that bleeding or spotting is reported in the last 3 cycles (90 days) of treatment.
Measured: Three months
Changes From Baseline in Albumin (g/dL)
Clinical safety will also be evaluated by changes from baseline through end of treatment of blood chemistry and hematologic profile to assess safety of the three treatment groups.
Measured: Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening)
Changes From Baseline in ALT/SGPT (U/L)
Clinical safety will also be evaluated by changes from baseline through end of treatment of blood chemistry and hematologic profile to assess safety of the three treatment groups.
Measured: Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening)
Changes From Baseline in AST/SGOT (U/L)
Clinical safety will also be evaluated by changes from baseline through end of treatment of blood chemistry and hematologic profile to assess safety of the three treatment groups.
Measured: Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening)
Changes From Baseline in BUN (mg/dL)
Clinical safety will also be evaluated by changes from baseline through end of treatment of blood chemistry and hematologic profile to assess safety of the three treatment groups.
Measured: Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening)
Changes From Baseline in Calcium (mg/dL)
Clinical safety will also be evaluated by changes from baseline through end of treatment of blood chemistry and hematologic profile to assess safety of the three treatment groups.
Measured: Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening)
Changes From Baseline in Creatinine (mg/dL)
Clinical safety will also be evaluated by changes from baseline through end of treatment of blood chemistry and hematologic profile to assess safety of the three treatment groups.
Measured: Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening)
Changes From Baseline in Glucose (mg/dL)
Clinical safety will also be evaluated by changes from baseline through end of treatment of blood chemistry and hematologic profile to assess safety of the three treatment groups.
Measured: Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening)
Changes From Baseline in GGT (U/L)
Clinical safety will also be evaluated by changes from baseline through end of treatment of blood chemistry and hematologic profile to assess safety of the three treatment groups.
Measured: Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening)
Changes From Baseline in Total Bilirubin (mg/dL)
Clinical safety will also be evaluated by changes from baseline through end of treatment of blood chemistry and hematologic profile to assess safety of the three treatment groups.
Measured: Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening)
Changes From Baseline in Total Protein (g/dL)
Clinical safety will also be evaluated by changes from baseline through end of treatment of blood chemistry and hematologic profile to assess safety of the three treatment groups.
Measured: Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening)
Changes From Baseline in Total Cholesterol (mg/dL)
Clinical safety will also be evaluated by changes from baseline through end of treatment of blood chemistry and hematologic profile to assess safety of the three treatment groups.
Measured: Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening)
Changes From Baseline in HDL Cholesterol (mg/dL)
Clinical safety will also be evaluated by changes from baseline through end of treatment of blood chemistry and hematologic profile to assess safety of the three treatment groups.
Measured: Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening)
Changes From Baseline in LDL Cholesterol (mg/dL)
Clinical safety will also be evaluated by changes from baseline through end of treatment of blood chemistry and hematologic profile to assess safety of the three treatment groups.
Measured: Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening)
Changes From Baseline in Triglycerides (mg/dL)
Clinical safety will also be evaluated by changes from baseline through end of treatment of blood chemistry and hematologic profile to assess safety of the three treatment groups.
Measured: Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening)
Changes From Baseline in Chloride (mmol/L)
Clinical safety will also be evaluated by changes from baseline through end of treatment of blood chemistry and hematologic profile to assess safety of the three treatment groups.
Measured: Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening)
Changes From Baseline in Potassium (mmol/L)
Clinical safety will also be evaluated by changes from baseline through end of treatment of blood chemistry and hematologic profile to assess safety of the three treatment groups.
Measured: Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening)
Changes From Baseline in Sodium (mmol/L)
Clinical safety will also be evaluated by changes from baseline through end of treatment of blood chemistry and hematologic profile to assess safety of the three treatment groups.
Measured: Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening)
Changes From Baseline in RBC (MIL/uL)
Clinical safety will also be evaluated by changes from baseline through end of treatment of blood chemistry and hematologic profile to assess safety of the three treatment groups.
Measured: Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening)
Changes From Baseline in WBC (THOU/uL)
Clinical safety will also be evaluated by changes from baseline through end of treatment of blood chemistry and hematologic profile to assess safety of the three treatment groups.
Measured: Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening)
Changes From Baseline in Hemoglobin (g/dL)
Clinical safety will also be evaluated by changes from baseline through end of treatment of blood chemistry and hematologic profile to assess safety of the three treatment groups.
Measured: Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening)
Changes From Baseline in Hematocrit (%)
Clinical safety will also be evaluated by changes from baseline through end of treatment of blood chemistry and hematologic profile to assess safety of the three treatment groups.
Measured: Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening)
Changes From Baseline in Platelet Count (THOU/uL)
Clinical safety will also be evaluated by changes from baseline through end of treatment of blood chemistry and hematologic profile to assess safety of the three treatment groups.
Measured: Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening)
Changes From Baseline in Basophils (%)
Clinical safety will also be evaluated by changes from baseline through end of treatment of blood chemistry and hematologic profile to assess safety of the three treatment groups.
Measured: Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening)
Changes From Baseline in Eosinophils (%)
Clinical safety will also be evaluated by changes from baseline through end of treatment of blood chemistry and hematologic profile to assess safety of the three treatment groups.
Measured: Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening)
Changes From Baseline in Lymphocytes (%)
Clinical safety will also be evaluated by changes from baseline through end of treatment of blood chemistry and hematologic profile to assess safety of the three treatment groups.
Measured: Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening)
Changes From Baseline in Monocytes (%)
Clinical safety will also be evaluated by changes from baseline through end of treatment of blood chemistry and hematologic profile to assess safety of the three treatment groups.
Measured: Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening)
Changes From Baseline in Neutrophils (%)
Clinical safety will also be evaluated by changes from baseline through end of treatment of blood chemistry and hematologic profile to assess safety of the three treatment groups.
Measured: Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2012 (estimated)
- Study startMar 2012
- Primary completionMay 2015
- Study completionMay 2015
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 Suppression of OvulationStudies 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
- None (open label)
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kimberly Myer
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Population Council
- Responsible party
- Sponsor-investigator, Kimberly Myer, Premier Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01586000
- Sponsor's protocol ID
- CCN012
- Status last verified
- Jun 2022
- First submitted
- 19 Mar 2012
- Last updated
- 8 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-finding Study to Evaluate the Effect of a Contraceptive Vaginal Ring, Releasing Nestorone® and Estradiol, on Cycle Control, Ovulation Inhibition, and Pharmacokinetics in Normal Cycling Women
- ClinicalTrials.gov ID
- NCT01586000
- Acronym / sponsor ID
- CCN012
- Conditions
- Suppression of Ovulation
- Keywords
- vaginal ring
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Kimberly MyerUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Population Council
- Study start
- Mar 2012
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 26 Apr 2012 (estimated)
- Results
- Posted 8 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial is an experimental research study using a potential new form of birth control. Clinical trials include people who volunteer to take part in a study. Take your time to decide if you want to be part of this experimental research study. If you want to know more about this study first, ask the study doctor or study site staff. The investigators can also give you the study information written for doctors and clinic staff.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 10 µg/day E2 | Experimental | Drug: 10 µg/day E2 with NES 200® µg/dayTwo consecutive 3-month (90-day) rings will be used continuously for six months (180 days). |
| 20 µg/day E2 | Experimental | Drug: 20 µg/day E2 with NES 200® µg/dayTwo consecutive 3-month (90-day) rings will be used continuously for six months (180 days). |
| 40 µg/day E2 | Experimental | Drug: 40 µg/day E2 with NES 200® µg/dayTwo consecutive 3-month (90-day) rings will be used continuously for six months (180 days). |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy women of reproductive age (18-39 years, inclusive, at the enrollment visit).
- Have a regular menstrual cycle that is 21-35 days in duration.
- Have intact uterus and both ovaries.
- Will be able and willing to comply with the protocol and sign an informed consent.
- Will not be at risk for pregnancy. They will be consistently using a non-hormonal method, have a surgically sterile male partner with a vasectomy, be abstinent, or be in a same-sex relationship from the control period through study exit (including recovery period).
Key exclusion criteria (50 listed)
- Women who meet any of the following criteria are not eligible for enrollment in the trial:
- Participating in another clinical trial involving an investigational product within the last 30 days (prior to screening) or planning to participate in another clinical trial during this study.
- Not living in the catchment area of the clinic.
- Known hypersensitivity to progestins or estrogen.
- All contraindications to combined estrogen-progestin contraceptive use including:
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 |
|---|---|---|
| 10 µg/day E2 with NES 200® µg/day10 µg/day E2 with NES 200® µg/day delivered by CVR continuously for 6 months (180 days) | Drug | 10 µg/day E2 |
| 20 µg/day E2 with NES 200® µg/day20 µg/day E2 with NES 200® µg/day delivered by CVR continuously for 6 months (180 days) | Drug | 20 µg/day E2 |
| 40 µg/day E2 with NES 200® µg/day40 µg/day E2 with NES 200® µg/day delivered by CVR continuously for 6 months (180 days) | Drug | 40 µg/day E2 |
Primary outcome
Number of Days Bleeding is Reported.
Time frame: Three months
The primary outcome will be the number of days that bleeding or spotting is reported in the first 3 cycles (90 days) of treatment.
31 secondary outcomes
Number of Subjects With Ovulation at During Each Cycle
Time frame: Control Cycle 1, Treatment Cycles 2, 3, and 7, Recovery Cycle 8, up to 8 months
Area Under the Curve of NES and E2 at Specified Time Points
Time frame: Visits 12, 32, and 41 (Treatment Period)
The Safety of Administering 200 µg/Day of NES and One of Three Doses (10, 20, or 40 µg/Day) of E2 Delivered by CVR Continuously for 6 Months (180 Days).
Time frame: Through Recovery Cycle 8, up to 8 months
Number of Days Bleeding is Reported.
Time frame: Three months
Changes From Baseline in Albumin (g/dL)
Time frame: Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening)
Changes From Baseline in ALT/SGPT (U/L)
Time frame: Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening)
Changes From Baseline in AST/SGOT (U/L)
Time frame: Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening)
Changes From Baseline in BUN (mg/dL)
Time frame: Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening)
Changes From Baseline in Calcium (mg/dL)
Time frame: Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening)
Changes From Baseline in Creatinine (mg/dL)
Time frame: Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening)
Changes From Baseline in Glucose (mg/dL)
Time frame: Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening)
Changes From Baseline in GGT (U/L)
Time frame: Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening)
Changes From Baseline in Total Bilirubin (mg/dL)
Time frame: Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening)
Changes From Baseline in Total Protein (g/dL)
Time frame: Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening)
Changes From Baseline in Total Cholesterol (mg/dL)
Time frame: Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening)
Changes From Baseline in HDL Cholesterol (mg/dL)
Time frame: Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening)
Changes From Baseline in LDL Cholesterol (mg/dL)
Time frame: Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening)
Changes From Baseline in Triglycerides (mg/dL)
Time frame: Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening)
Changes From Baseline in Chloride (mmol/L)
Time frame: Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening)
Changes From Baseline in Potassium (mmol/L)
Time frame: Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening)
Changes From Baseline in Sodium (mmol/L)
Time frame: Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening)
Changes From Baseline in RBC (MIL/uL)
Time frame: Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening)
Changes From Baseline in WBC (THOU/uL)
Time frame: Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening)
Changes From Baseline in Hemoglobin (g/dL)
Time frame: Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening)
Changes From Baseline in Hematocrit (%)
Time frame: Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening)
Changes From Baseline in Platelet Count (THOU/uL)
Time frame: Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening)
Changes From Baseline in Basophils (%)
Time frame: Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening)
Changes From Baseline in Eosinophils (%)
Time frame: Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening)
Changes From Baseline in Lymphocytes (%)
Time frame: Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening)
Changes From Baseline in Monocytes (%)
Time frame: Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening)
Changes From Baseline in Neutrophils (%)
Time frame: Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Suppression of Ovulation
RecruitingPhase 2
A Study to Investigate Mibavademab in Adult Women With Functional Hypothalamic Amenorrhea
Functional Hypothalamic Amenorrhea, FHA
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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 10 µg/day E2 with NES 200® µg/day, 20 µg/day E2 with NES 200® µg/day and 40 µg/day E2 with NES 200® µg/day in people with Suppression of Ovulation, run by Kimberly Myer at 8 sites 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 8 inclusion and 50 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 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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.
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?
Yes. Results are posted in the registry (first posted 8 Dec 2025). 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?
Number of Days Bleeding is Reported. (time frame: Three months). 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 Dec 2025.