Prospective, double-blind, randomised, placebo controlled, phase III clinical study assessing the efficacy of natural progesterone 25 mg/bid administered subcutaneously in the maintenance of early pregnancy in women with symptoms of threatened abortion.

Prospective, double-blind, randomised, placebo controlled, phase III clinical study assessing the efficacy of natural progesterone 25 mg/bid administered subcutaneously in the maintenance of early pregnancy in women with symptoms of threatened abortion. - Progesterone (Pleyrys)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002777-35-IT

Enrollment

268

Registered

2018-08-29

Start date

2017-01-18

Completion date

Unknown

Last updated

2018-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Threatened abortion MedDRA version: 20.1 Level: PT Classification code 10000242 Term: Abortion threatened System Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions MedDRA version: 20.0 Level: PT Classification code 10063273 Term: Progesterone normal System Organ Class: 10022891 - Investigations MedDRA version: 20.0 Level: PT Classification code 10063291 Term: Progesterone System Organ Class: 10022891 - Investigations MedDRA version: 20.0 Level: PT Classification code 1006

Interventions

Trade Name: PROLUTEX - 25 MG/ML SOLUZIONE INIETTABILE 1 FLACONCINO IN VETRO Pharmaceutical Form: Suspension for injection INN or Proposed INN: Progesterone Current Sponsor code: IBSA Concentration un

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Pregnant women attending the emergency room of the study sites with the following characteristics: - Able and willing to sign the Subject Informed Consent Form and adhere to the study visit schedule; - Age: 18-37 years; - BMI: 18-28 kg/m2; - Symptoms of threatened abortion (vaginal bleeding, pelvic pain); - Ultrasound proof of viable singleton intrauterine pregnancy (positive foetal heart beat); - Gestation week =6 weeks (5 w +1d) and =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Pregnancy obtained via ART treatment; - History of recurrent miscarriage; - Severe uterine malformations; - 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 or drugs affecting uterine contractility); - 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; - Known thyroid diseases or autoimmune conditions.

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective of this study will be to assess the efficacy of natural progesterone at a daily dose of 25 mg/bid in the maintenance of early pregnancy in women with symptoms of threatened abortion. ;Secondary Objective: The secondary objectives will be the efficacy of progesterone in reducing both pain and uterine contractions.;Primary end point(s): Ongoing pregnancy rate at 12 weeks of gestation;Timepoint(s) of evaluation of this end point: 12 weeks of gestation for the subject included in the study	—

Measure

Time frame

Main Objective: The main objective of this study will be to assess the efficacy of natural progesterone at a daily dose of 25 mg/bid in the maintenance of early pregnancy in women with symptoms of threatened abortion. ;Secondary Objective: The secondary objectives will be the efficacy of progesterone in reducing both pain and uterine contractions.;Primary end point(s): Ongoing pregnancy rate at 12 weeks of gestation;Timepoint(s) of evaluation of this end point: 12 weeks of gestation for the subject included in the study

—

Secondary

Measure	Time frame
Secondary end point(s): - Reduction of the frequency of uterine contractions; - Pain reduction (using a Numerical Rating Scale); - Reduction of subchorionic haematoma; - Number of subjects with onset of new threatened abortion symptoms after the treatment, but before the 12th week of pregnancy. ;Timepoint(s) of evaluation of this end point: 12 weeks	—

Countries

Italy

Contacts

Public ContactClinical Operations

PharmaD&S

edimartino@pharmades.it0557224179

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026