EndometriosisPhase 2PETALNCT00437658
Elagolix Versus Subcutaneous Depot Medroxyprogesterone Acetate for the Treatment of Endometriosis
A Phase 2 study testing Elagolix and Subcutaneous depot medroxyprogesterone acetate (DMPA-SC) in people with Endometriosis, run by AbbVie.
Trial summary
This study is designed to assess the effects of elagolix versus subcutaneous depot medroxyprogesterone acetate (DMPA-SC; also known as depo-provera) on bone mineral density (BMD) during treatment for 24 weeks with a subsequent 24-week post-treatment period. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Elagolix and Subcutaneous depot medroxyprogesterone acetate (DMPA-SC)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 252 participants
- Where
- No sites listed yet
- Study dates
- 11 Dec 2006to 24 Nov 2008
- 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 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Be female, aged 18 to 49 years, inclusive
- Have a total CPSSS of ≥ 6 at screening and baseline (Day 1) in the following categories: dysmenorrhea, dyspareunia, nonmenstrual pelvic pain, pelvic tenderness and induration. The total score must include a total of at least 2 in each of the categories of dysmenorrhea and nonmenstrual pelvic pain.
- Have had a diagnosis of endometriosis made following laparoscopic visualization of the disease within 8 years of the start of screening with recurrent or persistent symptoms.
- Have documented negative mammogram results within 12 months of screening if over the age of 40 years.
- Have menstrual cycles (28 days ±5 days). Assessment of cycle duration should be based on observations in the absence of drugs or conditions that are known to affect the cycle (e.g., oral contraceptives, leuprolide, pregnancy).
- Have a Body Mass Index (BMI) between 18 and 36 kg/m², inclusive.
- Agree to use two forms of nonhormonal contraception (e.g. condom with spermicide) during the study.
Who cannot join
- Are currently receiving gonadotropin-releasing hormone (GnRH) agonist, GnRH antagonist, danazol, or have received any of these agents within 6 months of the start of screening.
- Are currently receiving subcutaneous medroxyprogesterone acetate (DMPA-SC) or intramuscular medroxyprogesterone acetate (DMPA-IM) or have received any of these agents within 3 months of the start of screening.
- Have been nonresponsive to GnRH agonist or antagonist therapy for the management of endometriosis.
- Are currently using hormonal contraception or other forms of hormonal therapy or received such treatment within 1 month of the start of screening.
- Have had surgical treatment for endometriosis (laparoscopy) within 1 month of the start of screening.
- Have had a hysterectomy or bilateral oophorectomy.
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- Have had prior treatment with NBI-56418.
- Have uterine fibroids or other pelvic lesions ≥ 5 cm in diameter
- Have any of the following abnormal cervical smear results at screening (based on the 2001 Bethesda System):
- Benign endometrial cells (BEC) present, provided subject has irregular uterine bleeding or is over 40 years old
- Atypical squamous cells of undetermined significance (ASC-US) present, and human papilloma virus (HPV) reflex testing is positive for high risk types or the testing outcome is unknown
- Atypical squamous cells present, and high-grade squamous intraepithelial lesion (ASC-H) cannot be excluded
- Atypical glandular cells of uncertain significance (AGUS/AGC): not otherwise specified (NOS), favor neoplasia (FN), favor endocervical, or favor endometrial origin types
- Low-grade squamous intraepithelial lesion (LSIL) present
- High-grade squamous intraepithelial lesion (HSIL) present
- Adenocarcinoma in situ (AIS) / malignant cells present
- Have BMD with either lumbar spine or femur T-scores below -1.5 at screening as determined by the central DXA facility or have history of pathologic or compression fractures.
- Have been pregnant within 6 months of screening or currently breast feeding
- Are using systemic steroids on a chronic or regular basis within 3 months
- Have unstable medical condition or chronic disease
- Have chronic pelvic pain that is not caused by endometriosis
About this study
Official title: A Phase II, Randomized, Double-blind, Active-controlled Study to Assess the Safety and Efficacy of NBI-56418 in Subjects With Endometriosis
This study is designed to assess the effects of elagolix versus subcutaneous depot medroxyprogesterone acetate (DMPA-SC; also known as depo-provera) on bone mineral density (BMD) during treatment for 24 weeks with a subsequent 24-week post-treatment period.
- Conditions
- Endometriosis
- Being tested
- Elagolix, Subcutaneous depot medroxyprogesterone acetate (DMPA-SC), Placebo to Elagolix, Placebo to DMPA-SC
- 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 NBI-56418, Orilissa™
Provided as tablets for oral administration
Subcutaneous depot medroxyprogesterone acetate (DMPA-SC)Drug
Also called depo-subQ provera 104™
Provided for subcutaneous injection in a prefilled syringe, 104 mg/0.65 mL per syringe.
Placebo to ElagolixDrug
Matching placebo tablets for oral administration
Placebo to DMPA-SCDrug
Matching placebo for subcutaneous injection in a pre-filled syringe
| Study group | Role | What they receive |
|---|---|---|
| Elagolix 75 mg BID | Experimental | Participants received elagolix 75 mg orally twice a day (BID) for 24 weeks and placebo to DMPA-SC by subcutaneous injection at weeks 1 and 12. Receives: Drug: Elagolix; Drug: Placebo to DMPA-SC |
| Elagolix 150 mg QD | Experimental | Participants received elagolix 150 mg orally once a day (QD) for 24 weeks and placebo to DMPA-SC by subcutaneous injection at weeks 1 and 12. Receives: Drug: Elagolix; Drug: Placebo to DMPA-SC |
| DMPA-SC | Active comparator | Participants received placebo to elagolix orally once a day for 24 weeks and DMPA-SC 104 mg by subcutaneous injection at weeks 1 and 12. Receives: Drug: Subcutaneous depot medroxyprogesterone acetate (DMPA-SC); Drug: Placebo to Elagolix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in Bone Mineral Density of the Spine at Week 24
Bone mineral density (BMD) was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in spine and femur BMD at week 24 was assessed using a one-way analysis of variance (ANOVA) model. The absence of significant bone loss was supported if the lower bounds of the confidence intervals for the mean percent change in BMD were ≥ -2.2% for both the spine and femur at week 24.
Measured: Baseline and week 24
Percent Change From Baseline in Bone Mineral Density of the Femur at Week 24
Bone mineral density (BMD) was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in spine and femur BMD at week 24 was assessed using a one-way analysis of variance (ANOVA) model. The absence of significant bone loss was supported if the lower bounds of the confidence intervals for the mean percent change in BMD were ≥ -2.2% for both the spine and femur at week 24.
Measured: Baseline and week 24
Secondary outcomes (27)
Percent Change From Baseline in Bone Mineral Density of the Spine at Weeks 12 and 48
Bone mineral density (BMD) was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in BMD was assessed using a one-way analysis of variance (ANOVA) model.
Measured: Baseline and weeks 12 and 48
Percent Change From Baseline in Bone Mineral Density of the Femur at Weeks 12 and 48
Bone mineral density (BMD) was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in BMD was assessed using a one-way analysis of variance (ANOVA) model.
Measured: Baseline and weeks 12 and 48
Change From Baseline in N-telopeptide at Weeks 12, 24 and 48
Blood samples to determine N-telopeptide concentrations were analyzed by a central laboratory using an enzyme-linked immunosorbent assay (ELISA). Change from baseline in N-telopeptide was analyzed using a one-way ANOVA model.
Measured: Baseline and weeks 12, 24 and 48
Percentage of Participants With a Response in the Dysmenorrhea Component of the Composite Pelvic Signs and Symptoms Score (CPSSS) at Week 24
The CPSSS consists of 5 components that address dysmenorrhea (pain during menstruation), dyspareunia (painful intercourse), non-menstrual pelvic pain, pelvic tenderness, and pelvic induration (hardening). Each component was scored on a scale of 0 to 3 (0 = absent, 1 = mild, 2 = moderate, and 3 = severe). The dysmenorrhea score was based on the participant's response to the question "Have you had painful menstruation during the last 28 days?".
Participants were classified as responders for dysmenorrhea if they reported a 1 point or greater reduction (improvement) from baseline.
Measured: Baseline and week 24
Percentage of Participants With a Response in the Non-menstrual Pelvic Pain Component of the CPSSS at Week 24
The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration. Each component was scored on a scale of 0 to 3 (0 = absent, 1 = mild, 2 = moderate, and 3 = severe). The non-menstrual pelvic pain score was based on participant's response to the question "Have you had pelvic pain during the last 28 days?" Participants were classified as responders for non-menstrual pelvic pain if they reported a 1 point or greater reduction (improvement) from baseline.
Measured: Baseline and week 24
Percentage of Participants With a Response in the Dysmenorrhea Component of the CPSSS Over Time
The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration. Each component was scored on a scale of 0 to 3 (0 = absent, 1 = mild, 2 = moderate, and 3 = severe). The dysmenorrhea score was based on the participant's response to the question "Have you had painful menstruation during the last 28 days?".
Participants were classified as responders for dysmenorrhea if they reported a 1 point or greater reduction (improvement) from baseline.
Measured: Baseline and weeks 4, 8, 12, 16, 20, 24, 28, 36, and 48
Percentage of Participants With a Response in the Non-menstrual Pelvic Pain Component of the CPSSS Over Time
The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration. Each component was scored on a scale of 0 to 3 (0 = absent, 1 = mild, 2 = moderate, and 3 = severe). The non-menstrual pelvic pain score was based on participant's response to the question "Have you had pelvic pain during the last 28 days?" Participants were classified as responders for non-menstrual pelvic pain if they reported a 1 point or greater reduction (improvement) from baseline.
Measured: Baseline and weeks 4, 8, 12, 16, 20, 24, 28, 36, and 48
Change From Baseline in Total CPSSS During the Treatment Period
The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration. Each component was scored on a scale of 0 to 3 (0 = absent, 1 = mild, 2 = moderate, and 3 = severe).
Dysmenorrhea, dyspareunia, and nonmenstrual pelvic pain scores are based on the participant's assessment, pelvic tenderness and induration were assessed by the investigator based on findings associated with a pelvic examination.
The total CPSSS has a maximum possible value of 15 (total score range: 0 to 15, where a lower score indicates less signs and symptoms of endometriosis or better functioning).
Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.
Measured: Baseline and weeks 4, 8, 12, 16, 20, and 24
Change From Baseline in Total CPSSS Excluding Dyspareunia During the Treatment Period
The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration. Each component was scored on a scale of 0 to 3 (0 = absent, 1 = mild, 2 = moderate, and 3 = severe).
Dysmenorrhea, dyspareunia, and nonmenstrual pelvic pain scores are based on the participant's assessment, pelvic tenderness and induration were assessed by the investigator based on findings associated with a pelvic examination.
The total CPSSS excluding dyspareunia has a maximum possible value of 12 (total score range: 0 to 12, where a lower score indicates less signs and symptoms of endometriosis or better functioning).
Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.
Measured: Baseline and weeks 4, 8, 12, 16, 20, and 24
Change From Baseline in Dysmenorrhea Component of the CPSSS During the Treatment Period
The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration. Each component was scored on a scale of 0 to 3 (0 = absent, 1 = mild, 2 = moderate, and 3 = severe).
The dysmenorrhea score was based on the participant's response to the question "Have you had painful menstruation during the last 28 days?".
Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.
Measured: Baseline and weeks 4, 8, 12, 16, 20, and 24
Change From Baseline in Dyspareunia Component of the CPSSS During the Treatment Period
The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration. Each component was scored on a scale of 0 to 3 (0 = absent, 1 = mild, 2 = moderate, and 3 = severe).
The dyspareunia score was based on the participant's response to the question "Have you had painful intercourse during the last 28 days?" Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.
Measured: Baseline and weeks 4, 8, 12, 16, 20, and 24
Change From Baseline in Non-menstrual Pelvic Pain Component of the CPSSS During the Treatment Period
The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration. Each component was scored on a scale of 0 to 3 (0 = absent, 1 = mild, 2 = moderate, and 3 = severe).
The non-menstrual pelvic pain score was based on participant's response to the question "Have you had pelvic pain during the last 28 days?".
Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.
Measured: Baseline and weeks 4, 8, 12, 16, 20, and 24
Change From Baseline in Pelvic Tenderness Component of the CPSSS During the Treatment Period
The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration. Each component was scored on a scale of 0 to 3 (0 = absent, 1 = mild, 2 = moderate, and 3 = severe).
Pelvic tenderness was assessed by the investigator based on findings associated with a pelvic examination.
Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.
Measured: Baseline and weeks 4, 8, 12, 16, 20, and 24
Change From Baseline in Pelvic Induration Component of the CPSSS During the Treatment Period
The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration. Each component was scored on a scale of 0 to 3 (0 = absent, 1 = mild, 2 = moderate, and 3 = severe).
Pelvic induration was assessed by the investigator based on findings associated with a pelvic examination.
Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.
Measured: Baseline and weeks 4, 8, 12, 16, 20, and 24
Change From Baseline in in Monthly Peak Visual Analog Scale (VAS) for Pelvic Pain
The VAS for pelvic pain was used as an assessment of pain intensity. The VAS was a horizontal line on which the left extreme was labeled "no pain" and the right extreme was labeled "worst pain ever felt" scored on a scale from of 0 (no pain) to 100 (worst pain ever felt). Participants indicated the worst level of pain felt over a 24-hour period by ''ticking'' the horizontal line on their e-Diary at approximately the same time each day. Monthly peak VAS for pelvic pain was defined as the maximum VAS pain score reported for an individual participant from the previous visit to the day of the current scheduled visit.
Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.
Measured: Baseline and weeks 4, 8, 12, 16, 20, and 24
Change From Baseline in in Monthly Mean Visual Analog Scale (VAS) for Pelvic Pain
The VAS for pelvic pain was used as an assessment of pain intensity. The VAS was a horizontal line on which the left extreme was labeled "no pain" and the right extreme was labeled "worst pain ever felt" scored on a scale from of 0 (no pain) to 100 (worst pain ever felt). Participants indicated the worst level of pain felt over a 24-hour period by ''ticking'' the horizontal line on their e-Diary at approximately the same time each day. Monthly mean VAS for pelvic pain defined as the average of all VAS pain scores reported for an individual participant from the previous visit to the day of the current scheduled visit.
Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.
Measured: Baseline and weeks 4, 8, 12, 16, 20, and 24
Change From Baseline in Endometriosis Health Profile-5 (EHP-5) Pain Dimension
The EHP-5 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-5 consists of two parts:
- A core questionnaire consisting of five questions that measure the areas of pain, control and powerlessness, emotional well-being, social support, and self-image
- A supplemental questionnaire consisting of six additional questions, five of which were recorded in this study: work, relationship with children, sexual intercourse, feelings about the medical profession and treatment.
Each question was scored on a five point scale (Never = 0, Rarely = 25, Sometimes = 50, Often = 75, Always = 100), where 0 indicates the best health status and 100 worst health status. A negative change from baseline score indicates improvement in quality of life.
Measured: Baseline and weeks 4, 8, 12, 16, 20, and 24
Change From Baseline in EHP-5 Control and Powerlessness Dimension
The EHP-5 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-5 consists of two parts:
- A core questionnaire consisting of five questions that measure the areas of pain, control and powerlessness, emotional well-being, social support, and self-image
- A supplemental questionnaire consisting of six additional questions, five of which were recorded in this study: work, relationship with children, sexual intercourse, feelings about the medical profession and treatment.
Each question was scored on a five point scale (Never = 0, Rarely = 25, Sometimes = 50, Often = 75, Always = 100), where 0 indicates the best health status and 100 worst health status. A negative change from baseline score indicates improvement in quality of life.
Measured: Baseline and weeks 4, 8, 12, 16, 20, and 24
Change From Baseline in EHP-5 Emotional Well-being Dimension
The EHP-5 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-5 consists of two parts:
- A core questionnaire consisting of five questions that measure the areas of pain, control and powerlessness, emotional well-being, social support, and self-image
- A supplemental questionnaire consisting of six additional questions, five of which were recorded in this study: work, relationship with children, sexual intercourse, feelings about the medical profession and treatment.
Each question was scored on a five point scale (Never = 0, Rarely = 25, Sometimes = 50, Often = 75, Always = 100), where 0 indicates the best health status and 100 worst health status. A negative change from baseline score indicates improvement in quality of life.
Measured: Baseline and weeks 4, 8, 12, 16, 20, and 24
Change From Baseline in EHP-5 Social Support Dimension
The EHP-5 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-5 consists of two parts:
- A core questionnaire consisting of five questions that measure the areas of pain, control and powerlessness, emotional well-being, social support, and self-image
- A supplemental questionnaire consisting of six additional questions, five of which were recorded in this study: work, relationship with children, sexual intercourse, feelings about the medical profession and treatment.
Each question was scored on a five point scale (Never = 0, Rarely = 25, Sometimes = 50, Often = 75, Always = 100), where 0 indicates the best health status and 100 worst health status. A negative change from baseline score indicates improvement in quality of life.
Measured: Baseline and weeks 4, 8, 12, 16, 20, and 24
Change From Baseline in EHP-5 Self Image Dimension
The EHP-5 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-5 consists of two parts:
- A core questionnaire consisting of five questions that measure the areas of pain, control and powerlessness, emotional well-being, social support, and self-image
- A supplemental questionnaire consisting of six additional questions, five of which were recorded in this study: work, relationship with children, sexual intercourse, feelings about the medical profession and treatment.
Each question was scored on a five point scale (Never = 0, Rarely = 25, Sometimes = 50, Often = 75, Always = 100), where 0 indicates the best health status and 100 worst health status. A negative change from baseline score indicates improvement in quality of life.
Measured: Baseline and weeks 4, 8, 12, 16, 20, and 24
Change From Baseline in EHP-5 Work Dimension
The EHP-5 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-5 consists of two parts:
- A core questionnaire consisting of five questions that measure the areas of pain, control and powerlessness, emotional well-being, social support, and self-image
- A supplemental questionnaire consisting of six additional questions, five of which were recorded in this study: work, relationship with children, sexual intercourse, feelings about the medical profession and treatment.
Each question was scored on a five point scale (Never = 0, Rarely = 25, Sometimes = 50, Often = 75, Always = 100), or Not Relevant (no score), where 0 indicates the best health status and 100 worst health status. A negative change from baseline score indicates improvement in quality of life.
Measured: Baseline and weeks 4, 8, 12, 16, 20, and 24
Change From Baseline in EHP-5 Relationship With Children Dimension
The EHP-5 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-5 consists of two parts:
- A core questionnaire consisting of five questions that measure the areas of pain, control and powerlessness, emotional well-being, social support, and self-image
- A supplemental questionnaire consisting of six additional questions, five of which were recorded in this study: work, relationship with children, sexual intercourse, feelings about the medical profession and treatment.
Each question was scored on a five point scale (Never = 0, Rarely = 25, Sometimes = 50, Often = 75, Always = 100), or Not Relevant (no score), where 0 indicates the best health status and 100 worst health status. A negative change from baseline score indicates improvement in quality of life.
Measured: Baseline and weeks 4, 8, 12, 16, 20, and 24
Change From Baseline in EHP-5 Intercourse Dimension
The EHP-5 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-5 consists of two parts:
- A core questionnaire consisting of five questions that measure the areas of pain, control and powerlessness, emotional well-being, social support, and self-image
- A supplemental questionnaire consisting of six additional questions, five of which were recorded in this study: work, relationship with children, sexual intercourse, feelings about the medical profession and treatment.
Each question was scored on a five point scale (Never = 0, Rarely = 25, Sometimes = 50, Often = 75, Always = 100), or Not Relevant (no score), where 0 indicates the best health status and 100 worst health status. A negative change from baseline score indicates improvement in quality of life.
Measured: Baseline and weeks 4, 8, 12, 16, 20, and 24
Change From Baseline in EHP-5 Medical Profession Dimension
The EHP-5 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-5 consists of two parts:
- A core questionnaire consisting of five questions that measure the areas of pain, control and powerlessness, emotional well-being, social support, and self-image
- A supplemental questionnaire consisting of six additional questions, five of which were recorded in this study: work, relationship with children, sexual intercourse, feelings about the medical profession and treatment.
Each question was scored on a five point scale (Never = 0, Rarely = 25, Sometimes = 50, Often = 75, Always = 100), or Not Relevant (no score), where 0 indicates the best health status and 100 worst health status. A negative change from baseline score indicates improvement in quality of life.
Measured: Baseline and weeks 4, 8, 12, 16, 20, and 24
Change From Baseline in EHP-5 Treatment Dimension
The EHP-5 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-5 consists of two parts:
- A core questionnaire consisting of five questions that measure the areas of pain, control and powerlessness, emotional well-being, social support, and self-image
- A supplemental questionnaire consisting of six additional questions, five of which were recorded in this study: work, relationship with children, sexual intercourse, feelings about the medical profession and treatment.
Each question was scored on a five point scale (Never = 0, Rarely = 25, Sometimes = 50, Often = 75, Always = 100), or Not Relevant (no score), where 0 indicates the best health status and 100 worst health status. A negative change from baseline score indicates improvement in quality of life.
Measured: Baseline and weeks 4, 8, 12, 16, 20, and 24
Percentage of Participants Using Analgesics During the Treatment Phase
Analgesic use was collected as part of concomitant medications on a case report form that was administered at each scheduled visit.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2007 (estimated)
- Study start11 Dec 2006
- Primary completion24 Nov 2008
- Study completion24 Nov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AbbVie Inc., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00437658
- Sponsor's protocol ID
- NBI-56418-0603
- Acronym
- PETAL
- Status last verified
- Mar 2018
- First submitted
- 16 Feb 2007
- Last updated
- 12 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Double-blind, Active-controlled Study to Assess the Safety and Efficacy of NBI-56418 in Subjects With Endometriosis
- ClinicalTrials.gov ID
- NCT00437658
- Acronym / sponsor ID
- PETAL / NBI-56418-0603
- Conditions
- Endometriosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 11 Dec 2006 (actual)
- Primary completion
- 24 Nov 2008 (actual)
- Study completion
- 24 Nov 2008 (actual)
- First posted
- 21 Feb 2007 (estimated)
- Results
- Posted 12 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to assess the effects of elagolix versus subcutaneous depot medroxyprogesterone acetate (DMPA-SC; also known as depo-provera) on bone mineral density (BMD) during treatment for 24 weeks with a subsequent 24-week post-treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Elagolix 75 mg BID | Experimental | Drug: Elagolix, Drug: Placebo to DMPA-SCParticipants received elagolix 75 mg orally twice a day (BID) for 24 weeks and placebo to DMPA-SC by subcutaneous injection at weeks 1 and 12. |
| Elagolix 150 mg QD | Experimental | Drug: Elagolix, Drug: Placebo to DMPA-SCParticipants received elagolix 150 mg orally once a day (QD) for 24 weeks and placebo to DMPA-SC by subcutaneous injection at weeks 1 and 12. |
| DMPA-SC | Active comparator | Drug: Subcutaneous depot medroxyprogesterone acetate (DMPA-SC), Drug: Placebo to ElagolixParticipants received placebo to elagolix orally once a day for 24 weeks and DMPA-SC 104 mg by subcutaneous injection at weeks 1 and 12. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Be female, aged 18 to 49 years, inclusive
- Have a total CPSSS of ≥ 6 at screening and baseline (Day 1) in the following categories: dysmenorrhea, dyspareunia, nonmenstrual pelvic pain, pelvic tenderness and induration. The total score must include a total of at least 2 in each of the categories of dysmenorrhea and nonmenstrual pelvic pain.
- Have had a diagnosis of endometriosis made following laparoscopic visualization of the disease within 8 years of the start of screening with recurrent or persistent symptoms.
- Have documented negative mammogram results within 12 months of screening if over the age of 40 years.
- Have menstrual cycles (28 days ±5 days). Assessment of cycle duration should be based on observations in the absence of drugs or conditions that are known to affect the cycle (e.g., oral contraceptives, leuprolide, pregnancy).
Key exclusion criteria (21 listed)
- Are currently receiving gonadotropin-releasing hormone (GnRH) agonist, GnRH antagonist, danazol, or have received any of these agents within 6 months of the start of screening.
- Are currently receiving subcutaneous medroxyprogesterone acetate (DMPA-SC) or intramuscular medroxyprogesterone acetate (DMPA-IM) or have received any of these agents within 3 months of the start of screening.
- Have been nonresponsive to GnRH agonist or antagonist therapy for the management of endometriosis.
- Are currently using hormonal contraception or other forms of hormonal therapy or received such treatment within 1 month of the start of screening.
- Have had surgical treatment for endometriosis (laparoscopy) within 1 month of the start of 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: NBI-56418, Orilissa™Provided as tablets for oral administration | Drug | Elagolix 150 mg QD, Elagolix 75 mg BID |
| Subcutaneous depot medroxyprogesterone acetate (DMPA-SC)Also: depo-subQ provera 104™Provided for subcutaneous injection in a prefilled syringe, 104 mg/0.65 mL per syringe. | Drug | DMPA-SC |
| Placebo to ElagolixMatching placebo tablets for oral administration | Drug | DMPA-SC |
| Placebo to DMPA-SCMatching placebo for subcutaneous injection in a pre-filled syringe | Drug | Elagolix 150 mg QD, Elagolix 75 mg BID |
Primary outcome
Percent Change From Baseline in Bone Mineral Density of the Spine at Week 24
Time frame: Baseline and week 24
Bone mineral density (BMD) was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in spine and femur BMD at week 24 was assessed using a one-way analysis of variance (ANOVA) model. The absence of significant bone loss was supported if the lower bounds of the confidence intervals for the mean percent change in BMD were ≥ -2.2% for both the spine and femur at week 24.
Percent Change From Baseline in Bone Mineral Density of the Femur at Week 24
Time frame: Baseline and week 24
Bone mineral density (BMD) was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in spine and femur BMD at week 24 was assessed using a one-way analysis of variance (ANOVA) model. The absence of significant bone loss was supported if the lower bounds of the confidence intervals for the mean percent change in BMD were ≥ -2.2% for both the spine and femur at week 24.
27 secondary outcomes
Percent Change From Baseline in Bone Mineral Density of the Spine at Weeks 12 and 48
Time frame: Baseline and weeks 12 and 48
Percent Change From Baseline in Bone Mineral Density of the Femur at Weeks 12 and 48
Time frame: Baseline and weeks 12 and 48
Change From Baseline in N-telopeptide at Weeks 12, 24 and 48
Time frame: Baseline and weeks 12, 24 and 48
Percentage of Participants With a Response in the Dysmenorrhea Component of the Composite Pelvic Signs and Symptoms Score (CPSSS) at Week 24
Time frame: Baseline and week 24
Percentage of Participants With a Response in the Non-menstrual Pelvic Pain Component of the CPSSS at Week 24
Time frame: Baseline and week 24
Percentage of Participants With a Response in the Dysmenorrhea Component of the CPSSS Over Time
Time frame: Baseline and weeks 4, 8, 12, 16, 20, 24, 28, 36, and 48
Percentage of Participants With a Response in the Non-menstrual Pelvic Pain Component of the CPSSS Over Time
Time frame: Baseline and weeks 4, 8, 12, 16, 20, 24, 28, 36, and 48
Change From Baseline in Total CPSSS During the Treatment Period
Time frame: Baseline and weeks 4, 8, 12, 16, 20, and 24
Change From Baseline in Total CPSSS Excluding Dyspareunia During the Treatment Period
Time frame: Baseline and weeks 4, 8, 12, 16, 20, and 24
Change From Baseline in Dysmenorrhea Component of the CPSSS During the Treatment Period
Time frame: Baseline and weeks 4, 8, 12, 16, 20, and 24
Change From Baseline in Dyspareunia Component of the CPSSS During the Treatment Period
Time frame: Baseline and weeks 4, 8, 12, 16, 20, and 24
Change From Baseline in Non-menstrual Pelvic Pain Component of the CPSSS During the Treatment Period
Time frame: Baseline and weeks 4, 8, 12, 16, 20, and 24
Change From Baseline in Pelvic Tenderness Component of the CPSSS During the Treatment Period
Time frame: Baseline and weeks 4, 8, 12, 16, 20, and 24
Change From Baseline in Pelvic Induration Component of the CPSSS During the Treatment Period
Time frame: Baseline and weeks 4, 8, 12, 16, 20, and 24
Change From Baseline in in Monthly Peak Visual Analog Scale (VAS) for Pelvic Pain
Time frame: Baseline and weeks 4, 8, 12, 16, 20, and 24
Change From Baseline in in Monthly Mean Visual Analog Scale (VAS) for Pelvic Pain
Time frame: Baseline and weeks 4, 8, 12, 16, 20, and 24
Change From Baseline in Endometriosis Health Profile-5 (EHP-5) Pain Dimension
Time frame: Baseline and weeks 4, 8, 12, 16, 20, and 24
Change From Baseline in EHP-5 Control and Powerlessness Dimension
Time frame: Baseline and weeks 4, 8, 12, 16, 20, and 24
Change From Baseline in EHP-5 Emotional Well-being Dimension
Time frame: Baseline and weeks 4, 8, 12, 16, 20, and 24
Change From Baseline in EHP-5 Social Support Dimension
Time frame: Baseline and weeks 4, 8, 12, 16, 20, and 24
Change From Baseline in EHP-5 Self Image Dimension
Time frame: Baseline and weeks 4, 8, 12, 16, 20, and 24
Change From Baseline in EHP-5 Work Dimension
Time frame: Baseline and weeks 4, 8, 12, 16, 20, and 24
Change From Baseline in EHP-5 Relationship With Children Dimension
Time frame: Baseline and weeks 4, 8, 12, 16, 20, and 24
Change From Baseline in EHP-5 Intercourse Dimension
Time frame: Baseline and weeks 4, 8, 12, 16, 20, and 24
Change From Baseline in EHP-5 Medical Profession Dimension
Time frame: Baseline and weeks 4, 8, 12, 16, 20, and 24
Change From Baseline in EHP-5 Treatment Dimension
Time frame: Baseline and weeks 4, 8, 12, 16, 20, and 24
Percentage of Participants Using Analgesics During the Treatment Phase
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
AbbVie Inc. study director
AbbVie
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Elagolix and Subcutaneous depot medroxyprogesterone acetate (DMPA-SC) in people with Endometriosis, run by AbbVie.
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 7 inclusion and 21 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 12 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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 12 Oct 2018). 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?
Percent Change From Baseline in Bone Mineral Density of the Spine at Week 24 (time frame: Baseline and week 24). 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?
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 12 Oct 2018.