Trials / Withdrawn
WithdrawnNCT02950948
Progesterone in Luteal Phase Deficiency
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
- Status
- Withdrawn
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- IBSA Institut Biochimique SA · Industry
- Sex
- Female
- Age
- 20 Years – 35 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Progesterone | Progesterone will be administered subcutaneously once a day for 14 days/month, for 12 months. |
| DRUG | Placebo | A placebo solution will be administered subcutaneously once a day for 14 days/month, for 12 months. |
Timeline
- Start date
- 2017-05-03
- Primary completion
- 2019-03-01
- Completion
- 2019-12-01
- First posted
- 2016-11-01
- Last updated
- 2017-12-06
Source: ClinicalTrials.gov record NCT02950948. Inclusion in this directory is not an endorsement.