Progesterone in Luteal Phase Deficiency | NCT02950948

Studies
Progesterone in Luteal Phase Deficiency

NCT02950948

Sponsor

IBSA Institut Biochimique SA

Status

Withdrawn

Last Update Posted

Dec 6, 2017Actual

Enrollment

0Actual

Phase

Phase 3

Conditions

Luteal Phase Defect

Interventions

Progesterone
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

inability to recruit an adequate number of subjects.

Expanded Access Info

Start Date

May 3, 2017Actual

Primary Completion Date

Mar 2019Estimated

Completion Date

Dec 2019Estimated

First Submitted Date

Oct 27, 2016

First Submission Date that Met QC Criteria

Oct 31, 2016

First Posted Date

Nov 1, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 5, 2017

Last Update Posted Date

Dec 6, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Progesterone	Experimental	25 mg of progesterone will be administered daily by subcutaneous injection.	Drug: Progesterone
Placebo	Placebo Comparator	25 mg of progesterone will be administered daily by subcutaneous injection.	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Progesterone	Drug	Progesterone will be administered subcutaneously once a day for 14 days/month, for 12 months.	Progesterone

Measure	Description	Time Frame
Ongoing pregnancy rate at 12 weeks of gestation		12 weeks

Measure	Description	Time Frame
Rate of in phase endometrial biopsies		3 months
Length of luteal phase		3 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.
Normal uterine cavity;
Basal P4 level (day 3 of a previous cycle) ≤ 3ng/ml;
Non-smoking;
Fertile male partner (normal sperm count).

Exclusion Criteria:

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;
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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D011282	Pregnenediones
D011283	Pregnenes
D011278	Pregnanes
D013256	Steroids
D000072473