Luteal Phase DefectPhase 3NCT02950948
Progesterone in Luteal Phase Deficiency
A Phase 3 study testing Progesterone in people with Luteal Phase Defect, run by IBSA Institut Biochimique SA.
Trial summary
The main objective of this study will be to assess the efficacy of natural progesterone at a daily dose of 25 mg in restoring a normal luteal phase. The primary end-point will be the ongoing pregnancy rate. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Luteal Phase Defect
- What is being tested?
- Progesterone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 3 May 2017to Dec 2019
- 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 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women who wish to get pregnant with a previous diagnosis of luteal phase deficiency:
- Able and willing to sign the Subject Consent Form and adhere to the study visit schedule;
- Age: 20-35 years;
- BMI: 18-28 kg/m2;
- Inadequate luteal phase (menstrual period shorter than 21 days);
- Sub-fertile couple: 12 months of trying to conceive without success.
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- Normal uterine cavity;
- Basal P4 level (day 3 of a previous cycle) ≤ 3ng/ml;
- Non-smoking;
- Fertile male partner (normal sperm count).
Who cannot join
- History of recurrent miscarriage;
- Basal P4 level (day 3 of a previous cycle) > 3ng/ml;
- Severe uterine malformations (including submucosal fibroids, endometrial polyps, and intrauterine adhesions) ;
- Known hypersensitivity to study medication;
- Neoplasias (known or suspected breast or genital tract cancer);
- Severe impairment of hepatic or renal function;
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- Use of concomitant medications that might interfere with study evaluations (other hormonal treatment);
- Current vaginal infection;
- Endometriosis;
- PCOS;
- Partially or completed block of fallopian tubes;
- Hydrosalpinx;
- Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events;
- Porphyria;
- A history of idiopathic jaundice, severe pruritus or pemphigoid gestationis during pregnancy;
- Antiphospholipid syndrome;
- Diabetes mellitus;
- Thyroid diseases or autoimmune conditions;
- Hypothalamic dysfunction;
- Hyperprolactinaemia;
- Infertility due to male factor;
- Smokers.
About this study
Official title: Prospective, Randomised, Double-blind, Placebo Controlled, Phase III Clinical Study Assessing the Efficacy of 25 mg Natural Progesterone Administered Subcutaneously in Restoring the Normal Luteal Phase in Women With Previous Diagnosis of Luteal Phase Deficiency
The main objective of this study will be to assess the efficacy of natural progesterone at a daily dose of 25 mg in restoring a normal luteal phase. The primary end-point will be the ongoing pregnancy rate.
The secondary objectives will be the rate of endometrial biopsy showing an in phase endometrium after 3 months of treatment.
The length of the luteal phase of the menstrual cycle after treatment will also be assessed and compared with the initial duration (from LH peak to onset of menstruation).
- Conditions
- Luteal Phase Defect
- Being tested
- Progesterone, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProgesteroneDrug
Also called Test
Progesterone will be administered subcutaneously once a day for 14 days/month, for 12 months.
PlaceboDrug
Also called Control
A placebo solution will be administered subcutaneously once a day for 14 days/month, for 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Progesterone | Experimental | 25 mg of progesterone will be administered daily by subcutaneous injection. Receives: Drug: Progesterone |
| Placebo | Placebo comparator | 25 mg of progesterone will be administered daily by subcutaneous injection. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing pregnancy rate at 12 weeks of gestation
Measured: 12 weeks
Secondary outcomes (2)
Rate of in phase endometrial biopsies
Measured: 3 months
Length of luteal phase
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study start3 May 2017
- Primary completionMar 2019 (estimated)
- Study completionDec 2019 (estimated)
Why it stopped: inability to recruit an adequate number of subjects.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Luteal Phase DefectStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- IBSA Institut Biochimique SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02950948
- Sponsor's protocol ID
- 16I-Prg05
- Status last verified
- Dec 2017
- First submitted
- 27 Oct 2016
- Last updated
- 6 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomised, Double-blind, Placebo Controlled, Phase III Clinical Study Assessing the Efficacy of 25 mg Natural Progesterone Administered Subcutaneously in Restoring the Normal Luteal Phase in Women With Previous Diagnosis of Luteal Phase Deficiency
- ClinicalTrials.gov ID
- NCT02950948
- Acronym / sponsor ID
- 16I-Prg05
- Conditions
- Luteal Phase Defect
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: inability to recruit an adequate number of subjects.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- IBSA Institut Biochimique SAIndustry (pharma, biotech, devices)
- Study start
- 3 May 2017 (actual)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 1 Nov 2016 (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.
The main objective of this study will be to assess the efficacy of natural progesterone at a daily dose of 25 mg in restoring a normal luteal phase. The primary end-point will be the ongoing pregnancy rate.
The secondary objectives will be the rate of endometrial biopsy showing an in phase endometrium after 3 months of treatment.
The length of the luteal phase of the menstrual cycle after treatment will also be assessed and compared with the initial duration (from LH peak to onset of menstruation).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progesterone | Experimental | Drug: Progesterone25 mg of progesterone will be administered daily by subcutaneous injection. |
| Placebo | Placebo comparator | Drug: Placebo25 mg of progesterone will be administered daily by subcutaneous injection. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Women who wish to get pregnant with a previous diagnosis of luteal phase deficiency:
- Able and willing to sign the Subject Consent Form and adhere to the study visit schedule;
- Age: 20-35 years;
- BMI: 18-28 kg/m2;
- Inadequate luteal phase (menstrual period shorter than 21 days);
Key exclusion criteria (22 listed)
- History of recurrent miscarriage;
- Basal P4 level (day 3 of a previous cycle) > 3ng/ml;
- Severe uterine malformations (including submucosal fibroids, endometrial polyps, and intrauterine adhesions) ;
- Known hypersensitivity to study medication;
- Neoplasias (known or suspected breast or genital tract cancer);
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 |
|---|---|---|
| ProgesteroneAlso: TestProgesterone will be administered subcutaneously once a day for 14 days/month, for 12 months. | Drug | Progesterone |
| PlaceboAlso: ControlA placebo solution will be administered subcutaneously once a day for 14 days/month, for 12 months. | Drug | Placebo |
Primary outcome
Ongoing pregnancy rate at 12 weeks of gestation
Time frame: 12 weeks
2 secondary outcomes
Rate of in phase endometrial biopsies
Time frame: 3 months
Length of luteal phase
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2017.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Progesterone in people with Luteal Phase Defect, run by IBSA Institut Biochimique SA.
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 10 inclusion and 22 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: withdrawn, as of the sponsor's last update on 6 Dec 2017. 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. 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 withdrawn before enrolling participants, so there are no results.
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?
Ongoing pregnancy rate at 12 weeks of gestation (time frame: 12 weeks). 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 6 Dec 2017.