Secondary AmenorrheaPhase 3SPRYNCT02019589
A Phase 3, Randomized, Three-Cycle, Double-Blind, Placebo-Controlled Study to Evaluate Induction of Secretory Conversion of Endometrium and Withdrawal Bleeding for Secondary Amenorrhea
A Phase 3 study testing Progesterone in people with Secondary Amenorrhea, run by TherapeuticsMD at 22 sites in United States.
Trial summary
This study will be a Phase 3, randomized, three-cycle, double-blind, placebo-controlled, parallel group, multiple-dose design. The study design has four phases: Screening Period; Open-Label Estrogen-Priming Period (Run-In Period); Blinded Treatment Period; and Follow-Up. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Secondary Amenorrhea
- What is being tested?
- Progesterone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 22 sitesUnited States
- Study dates
- 20 Jan 2014to 31 Oct 2014
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Be female, premenopausal, 18 to 40 years of age (inclusive, at the time of randomization)
- Have secondary amenorrhea, defined as the absence of menstruation for at least 90 days prior to Visit 1 (Cycle 1, Day 1).
- Have an intact uterus.
- Be otherwise healthy, as judged by the Investigator physician, based on a medical evaluation performed during the screening period prior to the initial dose of Estrace®. The medical evaluation must include:
- a normal or non-clinically significant physical examination, including vital signs (sitting blood pressure, heart rate, respiratory rate and temperature). Acceptable sitting systolic blood pressure is <140 mmHg and diastolic blood pressure is <90 mmHg at screening. A subject may be taking up to two antihypertensive medications.
- a normal or non-clinically significant pelvic examination performed during screening.
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- a normal or non-clinically significant clinical breast examination performed during screening. An acceptable breast examination is defined as no masses, adenopathy, or other findings identified that are suspicious of malignancy.
- a normal or non-clinically significant 12-lead ECG as determined by the Principal Investigator (PI) or medical Sub-Investigator.
- Have a negative serum pregnancy test at Screening, and be willing to use an acceptable form of non-hormonal birth control (e.g., barrier method with spermicide) during the study. (The "rhythm method," withdrawal, or an IUD are NOT acceptable methods.)
- Exclusionary:
- Be postmenopausal.
- Be diagnosed with primary amenorrhea.
- Have had bilateral oophorectomy and/or hysterectomy.
- Have a history of thrombosis of deep veins or arteries or a thromboembolic disorder.
- Have a history of coronary artery or cerebrovascular disease (e.g., myocardial infarction, stroke, TIA).
- Have a history of liver or kidney dysfunction/disorder (e.g., hepatitis C or chronic renal failure).
- Have a history of gallbladder dysfunction/disorders (e.g., cholangitis, cholecystitis), unless gallbladder has been removed.
- Have a history of diabetes, thyroid disease or any other endocrine disease. (Subjects with diet-controlled diabetes or controlled hypothyroid disease at screening are not excluded.)
- Have a history of undiagnosed vaginal bleeding.
- Have any history of endometrial hyperplasia, uterine/endometrial, breast or ovarian cancer.
- Have any history of malignancy within the last 5 years, with the exception of basal cell (excluded if within one year) or squamous cell (excluded if within one year) carcinoma of the skin.
- Have a history of any other cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychological, or musculoskeletal disease or disorder that is clinically significant in the opinion of the Principal Investigator or medical Sub-Investigator.
- Have used injectable or implantable estrogen, progestin/progesterone, testosterone or androgens within the last 6 months prior to Visit 1 or plan to use them during the study.
- Have used any of the following hormonal products within the last 90 days prior to Visit 1 or plan to use them during the study:
- Vaginal nonsystemic hormonal products (rings, creams, gels) or vaginal systemic hormonal products (e.g., FemRing).
- Transdermal estrogen alone or combination estrogen and progestin/progesterone products.
- Oral hormonal birth control or oral estrogen and/or progestin/progesterone therapy.
- Percutaneous estrogen lotions/gels.
- Have used oral, topical, vaginal, or patch testosterone or androgen therapy within the last 8 weeks (56 days) prior to Visit 1 or plan to use them during the study.
- Have used injectable corticosteroids within the last 42 days prior to Visit 1 or plan to use them during the study.
- Have used an IUD (either hormonal or non-hormonal) within the previous 90 days prior to Visit 1 or plan to use one during the study.
- Have used, within 28 days prior to the initial dose of Estrace® at Baseline Visit 1, or plan to use during the study, any prescription or over-the-counter (OTC) medications (including herbal products, such as St. John's Wort) that would be expected to alter progesterone activity. (For additional details, see Concomitant and Prohibited Medications, Section 4.3.
- Have participated in another clinical trial within 30 days prior to screening, have received an investigational drug within the 90 days prior to the initial dose of Estrace®, or be likely to participate in a clinical trial or receive another investigational medication during the study.
- Have contraindication to any planned study assessments (e.g., endometrial biopsy).
Who cannot join
None listed.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
California Family Health Council
Berkeley, California, 94710
Precision Trials/New Horizons Women's Care
Chandler, Arizona, 85224
Chattanooga Medical Research
Chattanooga, Tennessee, 37404
University of Cincinnati Physicians Company
Cincinnati, Ohio, 45229
Vista Clinical Research
Columbia, South Carolina, 29201
Nature Coast Clinical Research
Crystal River, Florida, 34429
Methodist Charlton Medical Center
DeSoto, Texas, 75115
HWC Women's Research Center
Englewood, Ohio, 45322
The Woman's Hospital of Texas Clinical Research Center
Houston, Texas, 77054
Lawrence OB-Gyn Clinical Research
Lawrenceville, New Jersey, 08648
Women's Clinic of Lincoln, P.C.
Lincoln, Nebraska, 68510
California Family Health Council
Los Angeles, California, 90010
Clinical Research Consulting
Milford, Connecticut, 06460
Precision Clinical Trials/Arizona Wellness Center for Women
Phoenix, Arizona, 85032
Suffolk OBGYN
Port Jefferson, New York, 11777
Wake Research Associates
Raleigh, North Carolina, 27615
PRO/Salt Lake Women's Center
Sandy City, Utah, 84070
Visions Clinical Research
Tucson, Arizona, 85712
Tidewater Clinical Research
Virginia Beach, Virginia, 23456
Comprehensive Clinical Trials, LLC
West Palm Beach, Florida, 33409
Cypress Medical Research Center
Wichita, Kansas, 67226
Lyndhurst Clinical Research
Winston-Salem, North Carolina, 27103
About this study
Official title: A Phase 3, Randomized, Three-Cycle, Double-Blind, Placebo-Controlled Study to Evaluate Induction of Secretory Conversion of Endometrium and Withdrawal Bleeding After Administration of TX-12-002-HR in Estrogen-Primed Women With Secondary Amenorrhea
This study will be a Phase 3, randomized, three-cycle, double-blind, placebo-controlled, parallel group, multiple-dose design.
The study design has four phases: Screening Period; Open-Label Estrogen-Priming Period (Run-In Period); Blinded Treatment Period; and Follow-Up. The Open Label Priming Period and Blinded Treatment Period cover a total of three 28-day cycles. Clinical evaluations will be performed at the following time points:
Read more
Screening Period:
- Screening Period (approximately 42 Days)
Open-Label Estrogen Priming Period (Run In Period):
- Visit 1 Baseline (Cycle 1, Day 1)
- Telephone Interview (Cycle 1, Day 28 [- 3 d to ±1d])
Blinded Treatment Period:
- Visit 2 Randomization (Cycle 2, Day 12 [±2d])
- Visit 3 Interim (Cycle 3, Day 12 [±2d])
- Visit 4 End of treatment (Cycle 3, Day 24 [±1d])
Follow-Up Period:
- Visit 5 Follow-Up (Approximately 10 days after the last treatment)
- Telephone Interview (Approximately 2-4 weeks after completion of progestin course) (Only applies to subjects receiving an approved progestin therapy for proliferative endometrium, as determined by biopsy.)
- Conditions
- Secondary Amenorrhea
- Being tested
- Progesterone, Placebo
- Keywords
- Secondary Amenorrhea, SPRY Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProgesteroneDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Progesterone 225 mg/day | Active comparator | Progesterone + Placebo Receives: Drug: Progesterone; Drug: Placebo |
| Progesterone, 300 mg/ day | Active comparator | Progesterone + Placebo Receives: Drug: Progesterone; Drug: Placebo |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
• The proportion of subjects at Cycle 3 Day 24 ± 1 day on active treatment compared to placebo with complete secretory activity on endometrial biopsy.
Measured: 3 Cycles
Secondary outcomes (1)
• The proportion of subjects at Cycle 3 Day 24 ± 1 day on active treatment compared to placebo with total secretory activity (defined as the aggregate of partial and complete secretory activity) on endometrial biopsy.
Measured: 3 cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2013 (estimated)
- Study start20 Jan 2014
- Primary completion31 Oct 2014
- Study completion31 Oct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary AmenorrheaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- TherapeuticsMD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02019589
- Sponsor's protocol ID
- TXP13-01
- Acronym
- SPRY
- Status last verified
- May 2018
- First submitted
- 18 Dec 2013
- Last updated
- 8 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Three-Cycle, Double-Blind, Placebo-Controlled Study to Evaluate Induction of Secretory Conversion of Endometrium and Withdrawal Bleeding After Administration of TX-12-002-HR in Estrogen-Primed Women With Secondary Amenorrhea
- ClinicalTrials.gov ID
- NCT02019589
- Acronym / sponsor ID
- SPRY / TXP13-01
- Conditions
- Secondary Amenorrhea
- Keywords
- Secondary Amenorrhea, SPRY Trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 6 participants (actual)
- Lead sponsor
- TherapeuticsMDIndustry (pharma, biotech, devices)
- Study start
- 20 Jan 2014 (actual)
- Primary completion
- 31 Oct 2014 (actual)
- Study completion
- 31 Oct 2014 (actual)
- First posted
- 24 Dec 2013 (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 study will be a Phase 3, randomized, three-cycle, double-blind, placebo-controlled, parallel group, multiple-dose design.
The study design has four phases: Screening Period; Open-Label Estrogen-Priming Period (Run-In Period); Blinded Treatment Period; and Follow-Up. The Open Label Priming Period and Blinded Treatment Period cover a total of three 28-day cycles. Clinical evaluations will be performed at the following time points:
Screening Period:
- Screening Period (approximately 42 Days)
Open-Label Estrogen Priming Period (Run In Period):
- Visit 1 Baseline (Cycle 1, Day 1)
- Telephone Interview (Cycle 1, Day 28 [- 3 d to ±1d])
Blinded Treatment Period:
- Visit 2 Randomization (Cycle 2, Day 12 [±2d])
- Visit 3 Interim (Cycle 3, Day 12 [±2d])
- Visit 4 End of treatment (Cycle 3, Day 24 [±1d])
Follow-Up Period:
- Visit 5 Follow-Up (Approximately 10 days after the last treatment)
- Telephone Interview (Approximately 2-4 weeks after completion of progestin course) (Only applies to subjects receiving an approved progestin therapy for proliferative endometrium, as determined by biopsy.)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Progesterone 225 mg/day | Active comparator | Drug: Progesterone, Drug: PlaceboProgesterone + Placebo |
| Progesterone, 300 mg/ day | Active comparator | Drug: Progesterone, Drug: PlaceboProgesterone + Placebo |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (34 listed)
- Be female, premenopausal, 18 to 40 years of age (inclusive, at the time of randomization)
- Have secondary amenorrhea, defined as the absence of menstruation for at least 90 days prior to Visit 1 (Cycle 1, Day 1).
- Have an intact uterus.
- Be otherwise healthy, as judged by the Investigator physician, based on a medical evaluation performed during the screening period prior to the initial dose of Estrace®. The medical evaluation must include:
- Have a negative serum pregnancy test at Screening, and be willing to use an acceptable form of non-hormonal birth control (e.g., barrier method with spermicide) during the study. (The "rhythm method," withdrawal, or an IUD are NOT acceptable methods.)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progesterone | Drug | Progesterone 225 mg/day, Progesterone, 300 mg/ day |
| Placebo | Drug | Placebo, Progesterone 225 mg/day, Progesterone, 300 mg/ day |
Primary outcome
• The proportion of subjects at Cycle 3 Day 24 ± 1 day on active treatment compared to placebo with complete secretory activity on endometrial biopsy.
Time frame: 3 Cycles
1 secondary outcome
• The proportion of subjects at Cycle 3 Day 24 ± 1 day on active treatment compared to placebo with total secretory activity (defined as the aggregate of partial and complete secretory activity) on endometrial biopsy.
Time frame: 3 cycles
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Progesterone in people with Secondary Amenorrhea, run by TherapeuticsMD at 22 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 34 inclusion and 0 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: stopped early, as of the sponsor's last update on 8 May 2018. 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. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early. Results are not available in the source record.
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?
• The proportion of subjects at Cycle 3 Day 24 ± 1 day on active treatment compared to placebo with complete secretory activity on endometrial biopsy. (time frame: 3 Cycles). 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 May 2018.