FolliculogenesisPhase 1NCT01403038
An Open-label Study of the Effects of Elagolix in Adult Premenopausal Females
A Phase 1 study testing Elagolix in people with Folliculogenesis, run by AbbVie (prior sponsor, Abbott) at 22 sites in 2 countries.
Trial summary
This is an open-label Phase 1 study in healthy premenopausal females evaluating the effects of different dosing regimens of elagolix on ovarian activity, ovulation, and ovarian reserve and to assess the effect of elagolix on selected endocrine/hormone levels. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Folliculogenesis
- What is being tested?
- Elagolix
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 22 sitesin 2 countries
- Study dates
- Jun 2011to Nov 2012
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Premenopausal female, between 18 and 40 years of age, inclusive - History of regular menstrual cycles - Endocrine and ultrasonographic evidence of ovulation and normal ovulatory cycle during the screening period - Follicle-stimulating hormone level of <35 mIU/mL - Agrees to use required birth control methods during the entire length of participation in the study
Who cannot join
- Screening ultrasound results show a clinically significant gynecological disorder - Surgical history of hysterectomy without oophorectomy, unilateral or bilateral oophorectomy, removal of ovarian cysts - Less than 6 months postpartum or post-lactation at the start of study drug dosing - Pregnant or breast feeding or is planning a pregnancy within the next 12 months - Testosterone concentration >120 ng/dL at screening
Trial locations and contacts
22 sites in 2 countries.
22 sites in 2 countries
United States20 sites
Site Reference ID/Investigator# 50810
Cincinnati, Ohio, 45267-0457
Site Reference ID/Investigator# 50805
Colorado Springs, Colorado, 80910
Site Reference ID/Investigator# 51270
Colorado Springs, Colorado, 80917
Site Reference ID/Investigator# 50884
Denver, Colorado, 80246
Site Reference ID/Investigator# 50762
Durham, North Carolina, 27713
Site Reference ID/Investigator# 50404
Lonetree, Colorado, 80124
Site Reference ID/Investigator# 50904
Miami, Florida, 33126
Site Reference ID/Investigator# 50807
Naperville, Illinois, 60540
Site Reference ID/Investigator# 50902
Norfolk, Virginia, 23507
Site Reference ID/Investigator# 50804
Oak Brook, Illinois, 60523
Site Reference ID/Investigator# 50803
Philadelphia, Pennsylvania, 19104
Site Reference ID/Investigator# 51546
Philadelphia, Pennsylvania, 19114
Site Reference ID/Investigator# 50883
Portland, Oregon, 97239
Site Reference ID/Investigator# 50806
San Antonio, Texas, 78229
Site Reference ID/Investigator# 51342
San Antonio, Texas, 78229
Site Reference ID/Investigator# 50811
Sandy City, Utah, 84070
Site Reference ID/Investigator# 50882
Seattle, Washington, 98105
Site Reference ID/Investigator# 50402
South Miami, Florida, 33143
Site Reference ID/Investigator# 50808
Tampa, Florida, 33606
Site Reference ID/Investigator# 50403
Winston-Salem, North Carolina, 27103
Puerto Rico2 sites
Site Reference ID/Investigator# 53363
San Juan, 00935
Site Reference ID/Investigator# 53362
Santurce, 00910
About this study
Official title: A Phase 1, Open-Label Study of the Effects of Elagolix on Ovarian Activity, Ovulation and Ovarian Reserve in Premenopausal Females
This is an open-label Phase 1 study in healthy premenopausal females evaluating the effects of different dosing regimens of elagolix on ovarian activity, ovulation, and ovarian reserve and to assess the effect of elagolix on selected endocrine/hormone levels.
Read the detailed description
This is an open-label, multiple-dose, Phase 1 study in premenopausal subjects aged 18 years to 40 years, with a history of regular menstrual cycles (24 to 32 days long) and no evidence of significant gynecological disorders. The objective of the study is to determine the effects of different dosing regimens of elagolix on ovulation, ovarian activity, and ovarian reserve. The study consists of 3 periods: a Screening Period of up to 50 days prior to the first dose, a Treatment Period of 3 months duration (Cycles 1-3), and a Follow-up Period of up to 60 days. During the Screening and Treatment menstrual cycles, serial transvaginal ultrasounds and determination of serum levels of luteinizing hormone, follicle-stimulating hormone, estradiol, progesterone, and inhibin B will be performed three times weekly. Subjects will maintain a daily diary of uterine bleeding. Pregnancy testing will be performed frequently throughout the study. Subjects will be required to use nonhormonal dual contraception consistently during the study, and will be counseled on appropriate and effective forms of birth control to promote pregnancy prevention.
- Conditions
- Folliculogenesis
- Being tested
- Elagolix
- Keywords
- healthy volunteers, elagolix, endometriosis, ovarian reserve, gonadotropin-releasing hormone antagonist, ovulation, ovarian activity
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElagolixDrug
Also called ABT-620, elagolix sodium
Elagolix Dose Regimen 1 for 84 days
ElagolixDrug
Also called ABT-620, elagolix sodium
Elagolix Dose Regimen 2 for 84 days
ElagolixDrug
Also called ABT-620, elagolix sodium
Elagolix Dose Regimen 3 for 84 days
ElagolixDrug
Also called ABT-620, elagolix sodium
Elagolix Dose Regimen 4 for 84 days Other interventions may be added
ElagolixDrug
Also called ABT-620, elagolix sodium
Elagolix Dose Regimen 5 for 84 days
ElagolixDrug
Also called ABT-620, elagolix sodium
Elagolix Dose Regimen 6 for 84 days
elagolixDrug
Also called ABT-620, elagolix sodium
Elagolix plus Activella Dose Regimen 7 for 84 days
| Study group | Role | What they receive |
|---|---|---|
| Elagolix Dose Regimen 1 | Experimental | Elagolix Dose regimen 1 for 84 days Receives: Drug: Elagolix |
| Elagolix Dose Regimen 2 | Experimental | Elagolix Dose Regimen 2 for 84 days Receives: Drug: Elagolix |
| Elagolix Dose Regimen 3 | Experimental | Elagolix Dose Regimen 3 for 84 days Receives: Drug: Elagolix |
| Elagolix Dose Regimen 4 | Experimental | Elagolix Dose Regimen 4 for 84 days
Additional Dose Regimens may be added and will be administered for 84 days. Receives: Drug: Elagolix |
| Elagolix Dose Regimen 5 | Experimental | Elagolix Dose Regimen 5 for 84 days Receives: Drug: Elagolix |
| Elagolix Dose Regimen 6 | Experimental | Elagolix Dose Regimen 6 for 84 days Receives: Drug: Elagolix |
| Elagolix Dose Regimen 7 | Experimental | Elagolix Dose Regimen 7 for 84 days Receives: Drug: elagolix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ovulation Classification
Presence or absence of ovulation
Measured: During the baseline menstrual cycle and monthly during the treatment cycles 1, 2, and 3 for up to month 3.
Ovarian Activity
As measured by the Hoogland and Skouby 6-point ovarian activity grading system
Measured: During the baseline menstrual cycle and monthly during the treatment cycles 1, 2, and 3 for up to month 3.
Secondary outcomes (6)
Endocrine Parameters
Estuarial, Progesterone, luteinizing hormone, follicle stimulating hormone
Measured: During the 16 week study period (4 week screening period and 12 week treatment period) for up to month 3
Ovarian Reserve
Inhibin-B and Antimullerian hormone
Measured: During the baseline menstrual cycle and monthly during the treatment cycles 1, 2, and 3 for up to month 3.
Adverse events
All adverse events will be collected by subject self-report and review of laboratory parameters, physical exam. vital sign measurements and electrocardiograms.
Measured: All adverse events occurring through the Final Visit will be reported
Clinical Laboratory Tests
Chemistry, hematology, urinalysis
Measured: Change from baseline to Cycles 1, 2, and 3 or Final Visit
12-lead Electrocardiogram
12-lead Electrocardiogram
Measured: Change from baseline to Week 4 and Final Visit
Vital Signs
Blood pressure, heart rate, temperature
Measured: Change from baseline to Cycles 1, 2, and 3 or Final Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2011 (estimated)
- Study startJun 2011
- Primary completionOct 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FolliculogenesisStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Neurocrine Biosciences
- Responsible party
- Sponsor
- Investigators
- Kristof Chwalisz, MD, PhD, MD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01403038
- Sponsor's protocol ID
- M12-673
- Status last verified
- Jan 2013
- First submitted
- 1 Jun 2011
- Last updated
- 8 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Archer DF, Ng J, Chwalisz K, Chiu YL, Feinberg EC, Miller CE, Feldman RA, Klein CE. Elagolix Suppresses Ovulation in a Dose-Dependent Manner: Results From a 3-Month, Randomized Study in Ovulatory Women. J Clin Endocrinol Metab. 2020 Mar 1;105(3):dgz086. doi: 10.1210/clinem/dgz086.
PubMed 31650182Winzenborg I, Nader A, Polepally AR, Liu M, Degner J, Klein CE, Mostafa NM, Noertersheuser P, Ng J. Population Pharmacokinetics of Elagolix in Healthy Women and Women with Endometriosis. Clin Pharmacokinet. 2018 Oct;57(10):1295-1306. doi: 10.1007/s40262-018-0629-6.
PubMed 29476499
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label Study of the Effects of Elagolix on Ovarian Activity, Ovulation and Ovarian Reserve in Premenopausal Females
- ClinicalTrials.gov ID
- NCT01403038
- Acronym / sponsor ID
- M12-673
- Conditions
- Folliculogenesis
- Keywords
- healthy volunteers, elagolix, endometriosis, ovarian reserve, gonadotropin-releasing hormone antagonist, ovulation, ovarian activity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Collaborators
- Neurocrine Biosciences
- Study start
- Jun 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 27 Jul 2011 (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.
This is an open-label Phase 1 study in healthy premenopausal females evaluating the effects of different dosing regimens of elagolix on ovarian activity, ovulation, and ovarian reserve and to assess the effect of elagolix on selected endocrine/hormone levels.
Detailed description
This is an open-label, multiple-dose, Phase 1 study in premenopausal subjects aged 18 years to 40 years, with a history of regular menstrual cycles (24 to 32 days long) and no evidence of significant gynecological disorders. The objective of the study is to determine the effects of different dosing regimens of elagolix on ovulation, ovarian activity, and ovarian reserve. The study consists of 3 periods: a Screening Period of up to 50 days prior to the first dose, a Treatment Period of 3 months duration (Cycles 1-3), and a Follow-up Period of up to 60 days. During the Screening and Treatment menstrual cycles, serial transvaginal ultrasounds and determination of serum levels of luteinizing hormone, follicle-stimulating hormone, estradiol, progesterone, and inhibin B will be performed three times weekly. Subjects will maintain a daily diary of uterine bleeding. Pregnancy testing will be performed frequently throughout the study. Subjects will be required to use nonhormonal dual contraception consistently during the study, and will be counseled on appropriate and effective forms of birth control to promote pregnancy prevention.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Elagolix Dose Regimen 1 | Experimental | Drug: ElagolixElagolix Dose regimen 1 for 84 days |
| Elagolix Dose Regimen 2 | Experimental | Drug: ElagolixElagolix Dose Regimen 2 for 84 days |
| Elagolix Dose Regimen 3 | Experimental | Drug: ElagolixElagolix Dose Regimen 3 for 84 days |
| Elagolix Dose Regimen 4 | Experimental | Drug: ElagolixElagolix Dose Regimen 4 for 84 days Additional Dose Regimens may be added and will be administered for 84 days. |
| Elagolix Dose Regimen 5 | Experimental | Drug: ElagolixElagolix Dose Regimen 5 for 84 days |
| Elagolix Dose Regimen 6 | Experimental | Drug: ElagolixElagolix Dose Regimen 6 for 84 days |
| Elagolix Dose Regimen 7 | Experimental | Drug: elagolixElagolix Dose Regimen 7 for 84 days |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Premenopausal female, between 18 and 40 years of age, inclusive - History of regular menstrual cycles - Endocrine and ultrasonographic evidence of ovulation and normal ovulatory cycle during the screening period - Follicle-stimulating hormone level of <35 mIU/mL - Agrees to use required birth control methods during the entire length of participation in the study
Key exclusion criteria (1 listed)
- Screening ultrasound results show a clinically significant gynecological disorder - Surgical history of hysterectomy without oophorectomy, unilateral or bilateral oophorectomy, removal of ovarian cysts - Less than 6 months postpartum or post-lactation at the start of study drug dosing - Pregnant or breast feeding or is planning a pregnancy within the next 12 months - Testosterone concentration >120 ng/dL at screening
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 |
|---|---|---|
| ElagolixAlso: ABT-620, elagolix sodiumElagolix Dose Regimen 1 for 84 days | Drug | Elagolix Dose Regimen 1 |
| ElagolixAlso: ABT-620, elagolix sodiumElagolix Dose Regimen 2 for 84 days | Drug | Elagolix Dose Regimen 2 |
| ElagolixAlso: ABT-620, elagolix sodiumElagolix Dose Regimen 3 for 84 days | Drug | Elagolix Dose Regimen 3 |
| ElagolixAlso: ABT-620, elagolix sodiumElagolix Dose Regimen 4 for 84 days Other interventions may be added | Drug | Elagolix Dose Regimen 4 |
| ElagolixAlso: ABT-620, elagolix sodiumElagolix Dose Regimen 5 for 84 days | Drug | Elagolix Dose Regimen 5 |
| ElagolixAlso: ABT-620, elagolix sodiumElagolix Dose Regimen 6 for 84 days | Drug | Elagolix Dose Regimen 6 |
| elagolixAlso: ABT-620, elagolix sodiumElagolix plus Activella Dose Regimen 7 for 84 days | Drug | Elagolix Dose Regimen 7 |
Primary outcome
Ovulation Classification
Time frame: During the baseline menstrual cycle and monthly during the treatment cycles 1, 2, and 3 for up to month 3.
Presence or absence of ovulation
Ovarian Activity
Time frame: During the baseline menstrual cycle and monthly during the treatment cycles 1, 2, and 3 for up to month 3.
As measured by the Hoogland and Skouby 6-point ovarian activity grading system
6 secondary outcomes
Endocrine Parameters
Time frame: During the 16 week study period (4 week screening period and 12 week treatment period) for up to month 3
Ovarian Reserve
Time frame: During the baseline menstrual cycle and monthly during the treatment cycles 1, 2, and 3 for up to month 3.
Adverse events
Time frame: All adverse events occurring through the Final Visit will be reported
Clinical Laboratory Tests
Time frame: Change from baseline to Cycles 1, 2, and 3 or Final Visit
12-lead Electrocardiogram
Time frame: Change from baseline to Week 4 and Final Visit
Vital Signs
Time frame: Change from baseline to Cycles 1, 2, and 3 or Final Visit
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 8 Jan 2013.
- Derived from this study: PubMed 31650182Archer DF, Ng J, Chwalisz K, Chiu YL, Feinberg EC, Miller CE, Feldman RA, Klein CE. Elagolix Suppresses Ovulation in a Dose-Dependent Manner: Results From a 3-Month, Randomized Study in Ovulatory Women. J Clin Endocrinol Metab. 2020 Mar 1;105(3):dgz086. doi: 10.1210/clinem/dgz086.
- Derived from this study: PubMed 29476499Winzenborg I, Nader A, Polepally AR, Liu M, Degner J, Klein CE, Mostafa NM, Noertersheuser P, Ng J. Population Pharmacokinetics of Elagolix in Healthy Women and Women with Endometriosis. Clin Pharmacokinet. 2018 Oct;57(10):1295-1306. doi: 10.1007/s40262-018-0629-6.
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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.
Kristof Chwalisz, MD, PhD, MD study director
AbbVie
22 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Elagolix in people with Folliculogenesis, run by AbbVie (prior sponsor, Abbott) at 22 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 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 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Puerto Rico. 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?
Ovulation Classification (time frame: During the baseline menstrual cycle and monthly during the treatment cycles 1, 2, and 3 for up to month 3.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01403038, which also lists 2 linked publications.
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 Jan 2013.